Supportive care challenges in a resource limited oncology setting: prevalence and management of anthracycline and vinca alkaloid extravasation in Sudan

Abstract

Background

Chemotherapy extravasation is a serious complication of cancer treatment, particularly with vesicant agents such as anthracyclines and vinca alkaloids. Data from low-resource settings, particularly in Sudan remain limited. Therefore, this study aimed to determine the prevalence, clinical characteristics, associated factors, and management practices of anthracycline and vinca alkaloid extravasation.

Methods

A prospective cohort study was conducted from March to April 2023 including cancer patients receiving anthracyclines and/or vinca alkaloids at Khartoum Oncology Hospital, Sudan. Clinical and demographic data were collected using a structured form. Extravasation was assessed and graded using CTCAE v4.0. Data were analyzed using descriptive statistics and chi-square testing.

Results

Among 264 patients, 193 (73.1%) were female and 92 (34.8%) were aged 46–60 years. Breast cancer was the most common diagnosis 145 (54.9%). The prevalence of extravasation was 22 (8.3%); all cases occurred in patients who received chemotherapy via peripheral intravenous access. Most events occurred during previous cycles 14 (63.6%) and at first dose administration 11 (50.0%). The most frequent symptoms were phlebitis 17 (77.3%) and pain 13 (59.1%), with severe tissue injury in 5 patients (22.7%). Grade 2 extravasation was most common 17 (77.3%). No patients received pharmacological antidotes or supportive measures beyond stopping chemotherapy in 3 cases (14%). No significant associations were observed between extravasation and demographic or clinical variables (p > 0.05).

Conclusion

This study revealed a high prevalence of extravasation among patients receiving anthracyclines and vinca alkaloids, along with major deficiencies in management practices. The implementation of standardized protocols, staff training, and access to antidotes is urgently needed to improve patient safety in resource-limited oncology settings.

Introduction

Chemotherapy extravasation is defined as the accidental leakage of intravenously administered drugs into surrounding tissues, resulting in local injury of varying severity [1]. In oncology practice, this complication is of particular concern because many cytotoxic drugs, when deposited in the interstitial space, can cause progressive tissue damage, inflammation, functional impairment, and in severe cases, necrosis requiring surgical intervention [2, 3]. Extravasation not only worsens patient morbidity but may also delay ongoing chemotherapy cycles, thereby compromising treatment outcomes [4].

Cytotoxic agents differ considerably in their potential to cause tissue injury, and typically categorized into vesicants, irritants, and non-vesicants based on the extent of expected damage following extravasation [5]. Vesicant agents pose the greatest risk since they can trigger blistering, ulceration, and deep tissue necrosis [6]. Among these, anthracyclines and vinca alkaloids are recognized as the most clinically significant vesicant groups due to their high potential for inducing severe and progressive tissue injury [7–9]. Anthracyclines such as doxorubicin, and idarubicin are DNA-binding vesicants that persist in tissues and may cause ongoing cellular destruction [6]. In contrast, vinca alkaloids such as vincristine and vinorelbine are non-DNA-binding vesicants that typically cause immediate but less progressive injury [6, 10].

Despite recognition of extravasation as a clinically significant event, true incidence rates remain difficult to determine due to variability in reporting systems, monitoring practices, patient characteristics, and drug administration methods across hospitals and countries [11]. Globally, extravasation frequency has been reported between 0.1% and 6.5%, with higher rates documented in settings where peripheral venous catheters are predominantly used [1, 12]. Well-resourced centers in North America and Europe report lower rates, often below 0.1%, owing to strict protocols, specialized vascular access teams, and routine use of central venous catheters for vesicants [4, 9]. In contrast, resource-limited regions show higher frequencies, partly due to limited training, infrastructure gaps, and lack of standardized extravasation documentation procedures.

Risk factors for extravasation include patient-related factors such as fragile veins, and comorbidities that impair tissue perfusion [13]. Drug-related factors include vesicant classification, concentration, and infusion duration [3, 5]. Procedure-related factors such as improper venous access [14, 15].

Management of extravasation has evolved over the past decades. Historically, treatment relied on non-specific conservative measures such as cold or warm compresses, elevation, and saline washout [16]. However, the introduction of dexrazoxane, an FDA-approved antidote for anthracycline extravasation, represented a major advancement by reducing tissue necrosis [17]. Other interventions, such as topical dimethyl sulfoxide (DMSO) for non-anthracycline vesicants and hyaluronidase for vinca alkaloid extravasation, have shown clinical benefit in certain settings [18]. A systematic review in 2015 found insufficient evidence to clearly determine superiority among various management strategies, and most recommendations remain expert-opinion based [8]. Emerging modalities such as low level laser therapy (photobiomodulation) and digital tools like artificial intelligence (AI) assisted vascular access monitoring and early extravasation detection systems are being explored, but most remain inaccessible in low-resource oncology settings [7, 19].

In Sudan, despite widespread use of anthracyclines and vinca alkaloids in cancer treatment protocols, there is a pronounced lack of national data on extravasation prevalence, risk factors, and management practices. No standardized reporting system exists, and access to central venous devices or pharmacological antidotes is limited. As a result, understanding the local burden of chemotherapeutic extravasation and evaluating current management approaches are essential for improving oncology care quality and patient safety.The present study aims to address this gap by assessing the prevalence, characteristic, associated factors, and management practices of anthracycline and/or vinca alkaloid extravasation among cancer patients treated at the Khartoum Oncology Hospital (KOH), Sudan.

Methods

Study design

A prospective cohort study design.

Study setting

The study was conducted at KOH, the main national oncology referral center in Sudan. Established in 1967 after separation from Khartoum Teaching Hospital, it provides comprehensive cancer services, including chemotherapy, radiotherapy, surgical oncology, and palliative care to approximately 8,000 patients annually from across Sudan and neighboring countries. The hospital also functions as a major training and research hub, supported by specialized clinics and on-site laboratory, imaging, and pathology facilities, and routinely administers a wide range of chemotherapy regimens, including anthracyclines and vinca alkaloids [20]. Infusion rooms and wards were standard hospital clinical areas with routine ambient lighting.

Study population

The study included all adults or adolescents cancer patients who received chemotherapy containing anthracyclines and/or vinca alkaloids from March to April 2023.

Inclusion criteria

• Patients admitted to KOH who received at least one dose of anthracycline and/or vinca alkaloid.

• Complete medical records with all required clinical data.

• Willingness to participate and provision of informed consent by the patient or caregiver where applicable.

Exclusion criteria

• Patients receiving chemotherapy regimens without anthracyclines or vinca alkaloids.

• Incomplete or missing medical records relevant to extravasation assessment.

Sampling and sample size

Using Epi Info™ version 7.2.5.0, the required sample size was calculated as 93 patients, based on:

• Unknown population: Indicates the absence of a registry specifying the total number of patients receiving anthracyclines and/or vinca alkaloids.

• Confidence level: 95%,

• Expected frequency: The estimated prevalence of chemotherapy extravasation was 6.5% [1], derived from international literature reporting rates ranging from 0.1% to 6.5% among adult oncology patients receiving intravenous cytotoxic chemotherapy in hospital-based oncology settings. The upper limit of this range was selected due to the absence of local Sudanese data, the predominant use of peripheral intravenous access for vesicant administration, and the anticipated higher risk of extravasation in resource-limited settings.

• Margin of error: 5%.

• Design effect: 1.

• Single-cluster sampling approach: The single cluster was defined as KOH.

The sample size was initially calculated to ensure adequate statistical precision based on the expected incidence of chemotherapy extravasation. However, because all eligible patients receiving anthracyclines and/or vinca alkaloids during the study period were accessible, a total-coverage sampling strategy was ultimately employed. Consequently, all eligible patients were included, resulting in a final sample of 264 participants, which enhanced the robustness and representativeness of the study findings.

Data collection instrument and procedure

Data were collected using a structured data collection sheet specifically designed for this study. The tool was content-validated by a multidisciplinary panel of four experts (clinical pharmacist consultant, clinical pharmacologist, oncology specialist, and research methodology specialist) who independently assessed its relevance, clarity, comprehensiveness, and clinical applicability. Minor revisions were made to improve wording, flow, and completeness. Prior to data collection, the tool was tested for feasibility and clarity in the clinical setting, and data collectors received standardized training, serving as a practical pilot to ensure consistent and reliable data collection.

The instrument comprised 18 items divided into two main sections. The first section captured socio-demographic characteristics, including age, gender, body mass index (BMI), and other relevant anthropometric measurements. The second section focused on clinical and treatment related information, such as cancer type, existing comorbidities, chemotherapy drug class and specific agents administered, method of vascular access, and detailed documentation of extravasation events, including their presence, frequency, and timing. Additionally, this section covered the clinical manifestations of extravasation such as symptoms and signs and the grading and management practices applied. Data were collected by clinical pharmacist in close collaboration with the oncology team at KOH, after receiving standardized training to ensure proper clinical verification and consistency in documentation.

Baseline demographic and clinical data were collected at patient admission, treatment- and extravasation-related information was recorded at the start of chemotherapy administration and at the time of extravasation identification, and patients were followed up at the subsequent chemotherapy dose (day 21). Patients were asked for permission to obtain contact information for follow-up evaluation. Clinical photographs were obtained at the chemotherapy visit (Day 21) to document lesion progression or healing, as most patients declined photography at the time of extravasation. All images were obtained with informed consent, securely stored without identifiers, and used solely for clinical and research purposes.

All chemotherapy infusions during the study period were administered by trained oncology nurses according to routine institutional practice. Vesicant chemotherapy agents were not physician-administered at the study site. Chemotherapy was delivered exclusively through peripheral intravenous access using plastic cannulas.

Extravasation identification and grading

Extravasation events and associated symptoms were assessed and documented by oncologists and clinical staff after receiving standardized training on the data collection tool to ensure consistency. Grading was performed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0 [21]. This standardized grading system was selected because it is routinely used in clinical trials and feasible in low-resource settings, requiring no specialized diagnostic tools. The timing of extravasation recognition varied, with some events identified during chemotherapy administration in the clinic and others recognized after symptom onset reported by patients following discharge. However, the exact time interval between infusion and symptom detection could not be reliably quantified due to inconsistent documentation.

Data management and statistical analysis

Data were entered into a secure database and analyzed using Statistical Package for the Social Sciences (SPSS) version 27. Categorical variables were summarized using frequencies and percentages. Associations between potential contributing factors and the incidence of extravasation were assessed using the Chi-square (χ²) test or the Fisher’s exact test when appropriate. A p-value ≤ 0.05 with 95% confidence level was considered statistically significant.

Ethical considerations

Ethical approval was obtained from the Ethical Committee of the Ministry of Health, Khartoum State, Sudan, on 6 March 2023 (No: WKH/WSAATAA/44/A). All procedures involving human participants were performed in accordance with the principles of the Declaration of Helsinki. Written informed consent was obtained from all participants prior to data collection. For participants under the age of 16 years, written informed consent was obtained from their parents or legal guardians.

Results

Sociodemographic and clinical characteristics of studied patients

Among the studied patients (N = 264), the majority were female (193; 73.1%). Most patients were aged 46–60 years (92; 34.8%), followed by those aged 31–45 years (72; 27.3%). Regarding BMS, normal BMI (18 – < 25) was the most frequent category (110; 41.7%), while underweight patients constituted 55 (20.8%) (Table 1).

Table 1.

Sociodemographic characteristics of cancer patients receiving anthracycline and/or vinca alkaloid (N = 264)

Characteristics	Category	n (%)
Gender	Male	71(26.9)
	Female	193 (73.1)
Age (Years)	15–30	54 (20.5)
	31–45	72 (27.3)
	46–60	92 (34.8)
	61–75	40 (15.2)
	> 75	6 (2.3)
Body mass index	Under weight	55 (20.8)
	Normal	110 (41.7)
	Overweight	61 (23.1)
	Obese	38 (14.4)

The most common cancer diagnosis was breast cancer (145; 54.9%), followed by lymphomas (48; 18.2%) and Leukemias (37; 14.2%). Most patients had no comorbidities (213; 80.7%), while hypertension (26; 9.8%) and diabetes (14; 5.3%) were the most reported comorbid conditions (Table 2).

Table 2.

Clinical characteristics of cancer patients receiving anthracycline and/or vinca alkaloid (N = 264)

Characteristic	Category	n (%)
Diagnosis	Breast cancer	145 (54.9)
	Lymphomas	48 (18.2)
	Leukemias	37 (14.2)
	Sarcoma	21 (8.0)
	Others	16 (6.1)
Co-morbidity	No co-morbid disease	213 (80.7)
	Hypertension	26 (9.8)
	Diabetes	14 (5.3)
	Hypertension + diabetes	8 (3.0)
	Cardiovascular	1 (0.4)
	Others	2 (0.8)
Anticancer drug group	Anthracycline	146 (55.3)
	Vinca alkaloid	55 (20.8)
	Anthracycline + Vinca alkaloid	63 (23.9)
Specific anticancer drugs	Doxorubicin	104 (39.4)
	Doxorubicin and vincristine	45 (17.0)
	Epirubicin	33 (12.5)
	Vinorelbine	32 (12.1)
	Vincristine	20 (7.6)
	Doxorubicin and vinblastine	10 (3.8)
	Daunorubicin and vincristine	7 (2.7)
	Daunorubicin	7 (2.7)
	Vinblastine	6 (2.3)

Regarding treatment, over half of patients received anthracycline-based regimens (146; 55.3%), with doxorubicin being the most commonly used drug (104; 39.4%) (Table 2).

Prevalence and clinical characteristic of extravasation among the studied patients

Among the studied patients, 22 patients developed extravasation, giving an overall prevalence of 8.3%. All patients received chemotherapy through peripheral intravenous access 264 (100%). Most extravasation events 14 ( 63.6%) occurred during previous chemotherapy cycles prior to the current visit, while 6 (27.3%) were identified during the ongoing (immediate) chemotherapy cycle. Half of cases reported onset of symptoms during the first dose 11 (50.0%) (Table 3).

Table 3.

Extravasation prevalence and related clinical variables among cancer patients receiving anthracycline and/or vinca alkaloid

Clinical variable	Category	n (%)
Patient developed extravasation	Yes	22 (8.3)
	No	242 (91.7)
Administration method of chemotherapy	Peripheral intravenous access	264 (100.0)
	A central venous access	0 (0.0)
At which cycle did patient develop extravasation?	At current cycle	6 (27.3)
	At previous cycle	14 (63.6)
	At Immediate and previous cycles	2 (9.1)
How many extravasations did you have in previous cycles?	One time	13 (81.3)
	To time	2 (12.5)
	Three time	1 (6.2)
Onset of extravasation symptoms	1st dose	11 (50.0)
	2nd dose	5 (22.7)
	3rd dose	2 (9.1)
	Not remembered	4 (18.2)

Clinically, the most commonly reported symptom was pain (13; 59.1%), followed by phlebitis 17 (77.3%) and ulceration or necrosis 5 (22.7%). Severe tissue damage was reported in 5 cases (22.7%), while no cases required operative intervention or posed life-threatening consequences. Most cases were categorized as grade 2 extravasation 17 (77.3%), while grade 3 accounted for 5 cases (22.7%); no grade 1 or grade 4 injuries were reported (Table 4). Representative images of chemotherapy extravasation injuries are illustrated in Figs. 1, 2, 3 and 4. These images were captured at the chemotherapy visit (Day 21), as patients generally declined photography at the time of extravasation.

Table 4.

Clinical characteristics of extravasation among cancer patients receiving anthracycline and/or vinca alkaloid (N = 22)

Symptoms and signs	Category	n (%)
Edema	Yes	4 (18.2)
	No	18 (81.8)
Pain	Yes	13 (59.1)
	No	9 (40.9)
Induration	Yes	4 (18.2)
	No	18 (81.8)
Phlebitis	Yes	17 (77.3)
	No	5 (22.7)
Ulceration or necrosis	Yes	5 (22.7)
	No	17 (77.3)
Severe tissue damage	Yes	5 (22.7)
	No	17 (77.3)
Operative intervention indicated	Yes	0 (0.0)
	No	22 (100)
Life-threatening consequences or urgent intervention indicated	Yes	0 (0.0)
	No	22 (100)
Grading ╬	Grade 1	0 (0.0)
	Grade 2	204 (77.3)
	Grade 3	60 (22.7)
	Grade 4	0 (0.0)

╬, Grading was performed using the Common Terminology Criteria for Adverse Events (CTCAE) version 4.0

Fig. 1.

Severe grade 3 extravasation causing full-thickness ulcer with granulation tissue and peripheral necrotic eschar

Fig. 2.

Grade 3 extravasation presenting as hyperpigmented indurated lesion with overlying necrotic eschar

Fig. 3.

Grade 2 extravasation showing superficial epidermal loss with surrounding erythema and extensive forearm ecchymosis

Fig. 4.

Post-injury healing following resolution of a grade 2 extravasation

Management of extravasation

None of the affected patients received pharmacological antidotes or non-pharmacological supportive measures, such as cold or warm compresses, as these interventions were not available at the study site during the study period. The only action taken in 3 (14%) cases was stopping the chemotherapy, and none of the cases were managed according to the global established best-practice standards.

Factors associated with the prevalence of extravasation

There was no statistically significant association between sociodemographic variables and the prevalence of extravasation among the studied patients. Although females showed higher prevalence 18 (81.8%) compared to males 4 (18.2%) (p = 0.34). The highest incidence rate was observed in patients aged 46–60 years 8 (36.4%), followed by 15–30 years 7 (31.8%) (p = 0.58). Regarding BMI, extravasation occurred most among normal-weight patients 11 (50.0%) and underweight patients 7 (31.8%) (p = 0.23) (Table 5).

Table 5.

Sociodemographic factors associated with prevalence of extravasation among cancer patients receiving anthracycline and/or vinca alkaloid

Variable	Category	Extravasation		P value ╬
		Yes; n (%)	No; n (%)
Gender	Male	4 (18.2)	67 (27.7)	0.34
	Female	18 (81.8)	175 (72.3)
Age	15–30	7 (31.8)	47 (19.4)	0.58
	31–45	5 (22.7)	67 (27.7)
	46–60	8 (36.4)	84 (34.7)
	61–75	2 (9.1)	38 (15.7)
	> 75	0 (0.0)	6 (2.5)
Body mass index	Normal	11 (50.0)	99 (40.9)	0.23
	Overweight	3 (13.6)	58 (24.0)
	Obese	1 (4.5)	37 (15.3)
	underweight	7 (31.8)	48 (19.8)

╬, p value from chi square/ Fisher exact test

There was no statistically significant association between clinical characteristics and the prevalence of extravasation. Extravasation was most frequent in patients with breast cancer 11 (50.0%), followed by leukemia 5 (22.7%) (p = 0.47). With respect to treatment regimen, cases were highest among patients receiving anthracycline alone 10 (45.5%), followed by vinca alkaloids 8 (36.4%) (p = 0.17). Among individual drugs, extravasation was most common with doxorubicin 5 (22.7%), vincristine 4 (18.2%), and vinorelbine 4 (18.2%) (p = 0.19) (Table 6).

Table 6.

Clinical factors associated with prevalence of extravasation among cancer patients receiving anthracycline and/or vinca alkaloid

Variable	Category	Extravasation		P value ╬
		Yes; n (%)	No; n (%)
Type of cancer	Leukemias	5 (22.7)	28 (11.6)	0.47
	Lymphomas	2 (9.1)	46 (19.0)
	Breast	11 (50.0)	134 (55.4)
	Sarcoma	2 (9.1)	19 (7.9)
	Other	2 (9.1)	15 (6.2)
Anticancer group	Anthracycline	10 (45.5)	136 (56.2)	0.17
	Vinca alkaloids	8 (36.4)	47 (19.4)
	Anthracycline +Vinca alkaloids	4 (18.2)	59 (24.4)
Type of anticancer drugs	Doxorubicin	5 (22.7)	99 (40.9)	0.19
	Epirubicin	3 (13.6)	30 (12.4)
	Daunorubicin	2 (9.1)	5 (2.1)
	Vincristine	4 (18.2)	16 (6.6)
	Vinorelbine	4 (18.2)	28 (11.6)
	Vinblastine	0 (0.0)	6 (2.5)
	Doxorubicin and vincristine	3 (13.6)	42 (17.4)
	Doxorubicin and vinblastine	1 (4.5)	9 (3.7)
	Daunorubicin and vincristine	0 (0.0)	7 (2.9)

╬, p value from chi square/ Fisher exact test

Discussion

This study aimed to determine the prevalence, characteristic, associated factors, and management practices of anthracycline and/or vinca alkaloid extravasation among cancer patients in Sudan. In this study, the 8.3% prevalence of anthracycline and/or vinca alkaloid related extravasation is noticeably higher than most reported figures worldwide. Globally, chemotherapy extravasation rates generally range between 0.1% and 6.5% [1]. Rates reported from major cancer centers in North America and Europe are even lower, often below 0.1%, a difference attributed to stricter vascular access protocols and advanced infusion monitoring systems [9]. In contrast, Sudan lacks a formal extravasation reporting system, which limits early detection and prevention efforts and may contribute to the higher observed rate. All patients in this study received chemotherapy through peripheral intravenous access, a practice that further increases vulnerability to extravasation. Moreover, the continued reliance on peripheral intravenous catheters known to carry a greater risk of leakage than central venous catheters likely elevates local incidence relative to settings with more consistent central-line use [15]. In addition to access device differences, several contextual factors may further explain the higher prevalence observed in our setting. Variability in staff experience with vesicant administration, limited monitoring technologies, inconsistent reporting systems, and delays in antidote availability can all affect early detection and timely intervention. Evidence from the region supports this interpretation: a 2020 Iraqi study found that many oncology nurses lacked formal training and standardized procedures for managing extravasation, leading to inconsistent responses during emergencies [22]. Likewise, a 2022 Egyptian study reported low awareness of early extravasation signs among nurses, resulting in delayed intervention and increased risk of severe complications [23]. Similar findings were noted in Sudan in 2022, where despite training efforts, the absence of standardized guidelines and routine competency verification contributed to variations in practice and compromised patient safety [24]. Furthermore, the observed findings are likely driven by context-specific factors, including cumulative venous injury across repeated treatment cycles, and absence of standardized extravasation management protocols, all of which may increase both the prevalence and clinical impact of chemotherapy extravasation in resource-limited oncology settings. Collectively, these findings highlight that enhanced nursing education, establishment of clear protocols, and regular skill assessments are essential to reducing extravasation rates and improving patient outcomes.

In our study, extravasation events predominantly occurred during previous treatment cycles and were frequently associated with first-dose administration, a pattern comparable with adult outpatient findings reported by Sakaida et al., who support observed events arising after 2.1–5.0 after starting infusion chemotherapy [12], suggesting that cumulative venous exposure and repeated cannulation may increase vulnerability over time. Across this study, pain was the most common presenting symptom, and the predominance of phlebitis with comparatively low rates of ulceration or necrosis in our cohort aligns with Sakaida’s adult population and the Chinese children [12, 25], in which pain and swelling were key early indicators and severe tissue injury remained uncommon, indicating that timely recognition generally prevents progression to necrosis. With respect to severity grading, our distribution characterized mainly by Grade 2 events with a smaller proportion of Grade 3 was greater than that described in the adult outpatient chemotherapy clinic [12], which was largely limited to Grade 1 reactions (80%), yet less severe overall than the Chinese children, which included Grades 1 through 4 [25]. Taken together, these similarities suggest that the underlying trajectory of extravasation early pain, moderate severity, and limited tissue destruction is consistent across populations when monitoring protocols are in place. Despite this intermediate severity profile, no patients in our study required surgical intervention, mirroring the absence of surgical management in the adult outpatient chemotherapy clinic and comparable to the very limited need for surgery reported in the pediatric Chinese population [12, 25]. Collectively, the congruence across these studies supports a consistent theme: extravasation is typically recognized early, presents with similar symptomatology, demonstrates moderate severity in adult populations, and rarely progresses to complications necessitating surgical management. Clinically, these findings highlight the need to strengthen pain triggered early detection, ensure secure vascular access during both initial and repeated chemotherapy cycles, and maintain structured extravasation management protocols. Implementing routine staff training, standardized infusion time symptom checklists, and clear early escalation pathways can further minimize severe complications and help preserve the consistently low surgical intervention rates observed across studies.

In this study, none of the affected patients received pharmacological antidotes or non-pharmacological measures such as cold or warm compresses; management was limited to stopping chemotherapy in 14% of cases, and no patient received care aligned with global best-practice standards [1, 4, 11]. These established best-practice standards recommend immediate cessation of infusion, appropriate local measures, use of specific antidotes, and close clinical follow-up. At the study site, no formal institutional protocol was available, and no access to recommended antidotes and supportive interventions; thus, observed practices reflect system-level resource constraints rather than intentional omission of care. Inadequate management of extravasation may result in significant morbidity, including pain, tissue injury, ulceration or necrosis, functional impairment, treatment delay, and potential need for surgical intervention [2–4], underscoring the ethical and clinical imperative for standardized protocols and improved resource availability. Although dexrazoxane has markedly improved anthracycline extravasation outcomes by reducing tissue necrosis through inhibition of iron-dependent free radical formation [17], and other agents such as topical DMSO and hyaluronidase show benefit for various vesicants [18], access to these antidotes remains limited in many regions. A 2015 systematic review similarly concluded that evidence is insufficient to determine superiority among existing strategies, with most guidelines recommendations remaining expert opinion based [8]. Emerging modalities, including photobiomodulation [19] and digital technologies such as AI-assisted vascular monitoring [7], offer potential improvement but remain largely unavailable in low-resource settings, highlighting persistent global disparities. Implementing context appropriate protocols, ensuring antidote availability, and strengthening staff training may help bridge these gaps and move practice closer to established international standards.

This study found no significant associations between sociodemographic or clinical characteristics and prevalence of extravasation. Although certain groups showed higher observed frequencies, these differences were not statistically meaningful. Similar findings have been reported in adult outpatient settings, where demographic variables such as age and sex have not been reliable predictors of extravasation [12]. Clinical factors including cancer type, chemotherapy regimen, and specific drugs also showed no significant association with extravasation. Prior literature indicates that extravasation occurs across a wide range of agents, with infusion-related and vein-related factors often playing a more important role than patient or treatment characteristics [12, 25]. Importantly, multivariable regression analysis could not be performed because several categories contained very low frequencies, resulting in unstable estimates and model non-convergence. This limitation reflects the inherently low prevalence of extravasation and restricted variability within certain subgroups; therefore, the absence of statistically significant associations should be interpreted with caution and does not preclude the existence of true relationships. Overall, the lack of significant associations supports the view that extravasation is a multifactorial event. Therefore, prevention should focus on meticulous infusion practices, careful catheter assessment, and adherence to standardized monitoring protocols rather than expecting demographic or clinical factors to predict risk reliably.

This study provides important insight into the prevalence and management of anthracycline and vinca alkaloid extravasation in a resource-limited oncology setting. The observed prevalence was higher than most international reports, reflecting the absence of central venous access devices, lack of local standardized monitoring protocols, and limited availability of antidotes in Sudan. In the absence of routine central venous access, implementation of a standardized, context-appropriate chemotherapy extravasation prevention and management protocol is critical. These include: [1] standardized pre-infusion vein assessment and site selection; [2] administration of vesicant chemotherapy by trained oncology nurses; [3] verification of catheter patency before and during infusion; [4] continuous visual monitoring during vesicant administration; [5] patient education on early symptom reporting; [6] immediate standardized response to suspected extravasation; and [7] systematic documentation and reporting of all events, with phased incorporation of staff training and antidote availability as resources permit. Although the clinical presentation and severity grading in the studied patients were comparable to reports from other regions, management practices were markedly inadequate and did not follow established global guidelines. Importantly, no predictive clinical or demographic factors were identified, underscoring the necessity of universal preventive strategies rather than selective risk-based interventions. Collectively, these findings highlight critical gaps in infrastructure, training, and clinical preparedness that directly affect patient safety. Addressing these gaps through protocol development, workforce education, and access to essential therapies is vital for improving outcomes and reducing preventable injury in oncology patients.

Strength and limitations

This study is one of the first prospective investigations in Sudan to specifically examine extravasation associated with anthracyclines and vinca alkaloids. The use of a standardized grading system (CTCAE v4.0) strengthened clinical consistency and comparability with international studies. Inclusion of all eligible patients during the study period minimized selection bias and improved representativeness. In addition, direct clinical verification of events by oncology staff increased diagnostic reliability.

However, this study have some limitations. It was conducted at a single center, which may limit generalizability to other oncology facilities in Sudan and similar settings. Despite an adequate overall sample size, the low prevalence of chemotherapy extravasation yielded a small number of outcome events, which limited statistical power and increased the risk of type II error. As a result, analyses were confined to univariate comparisons, and the absence of statistically significant associations should be interpreted cautiously. Absence of longitudinal follow-up prevented evaluation of long-term sequelae. Furthermore, the absence of detailed documentation on vein quality, nursing experience, infusion environment, cannula characteristics, and precise timing of symptom onset limited a comprehensive assessment of procedure-related risk factors for extravasation. Finally, the unavailability of antidotes may have influenced severity outcomes and management patterns, and thus may not reflect settings with access to full therapeutic options.

Conclusion

Chemotherapy extravasation involving anthracyclines and vinca alkaloids remains a significant, under-addressed complication in Sudanese oncology practice. The prevalence observed in this study exceeds most international estimates and reflects systemic shortages in vascular access, staff training, and therapeutic resources. Management was largely inconsistent with global standards, with no patient receiving evidence-based treatment. Although no strong predictors of extravasation were identified, the findings emphasize the urgent need for standardized clinical protocols, structured staff education, and access to essential antidotes. Strengthening supportive care services is essential to enhancing patient safety and treatment continuity. Future multicenter studies and national surveillance systems are recommended to guide policy development and improve cancer care delivery across Sudan.

Abbreviations

DMSO

Dimethyl sulfoxide

AI

Artificial intelligence

KOH

The Khartoum oncology hospital

BMI

Body mass index

CTCAE

Common terminology criteria for adverse events

SPSS

Statistical package for the social sciences

Authors’ contributions

ARA, BAY, and EAAE conceived and designed the study. ARA contributed to patient recruitment, data acquisition, and conducting the study. ARA, YBH, MAM, and MHA performed data analysis and interpreted the results. EAAE supervised the research. All the authors contributed to the writing of the first draft of the manuscript. YBH edited the final draft and provided critical revisions. All the authors reviewed, edited, and approved the final manuscript.

Funding

This research did not receive any specific grant from funding agencies in the public, commercial, or not-for-profit sectors.

Data availability

The datasets used and/or analyzed during the current study are available from the corresponding author upon reasonable request.

Declarations

Ethics approval and consent to participate

Ethical approval was obtained from the Ethical Committee of the Ministry of Health, Khartoum State, Sudan, on 6 March 2023 (No: WKH/WSAATAA/44/A). All procedures involving human participants were performed in accordance with the principles of the Declaration of Helsinki and its subsequent amendments. Written informed consent was obtained from all participants prior to data collection. For participants under the age of 16 years, written informed consent was obtained from their parents or legal guardians.

Consent for publication

Consent for publication was obtained, and images of the affected areas were captured to support documentation and clinical assessment.

Competing interests

The authors declare no competing interests.