Efficacy of Eicosapentaenoic Acid (EPA) Containing Protein Supplement in Preventing Weight Loss in Head and Neck Cancer Patients Undergoing Curative Radiotherapy: Retrospective Observations with Historical Controls

Abstract

Weight loss is a major issue in Head and Neck cancer (HNC) patients undergoing curative radiotherapy. The principal objective of the study was to observe whether eicosapentaenoic acid (EPA) containing protein supplement was effective in mitigating the weight loss during in hospitalized HNC undergoing curative radiotherapy. A retrospective study was performed based on clinical, treatment and nutritional data of 53 patients received EPA containing supplement during their curative radiotherapy from October 2014 to January 2015 and was compared with 88 historical control group of patients (October 2013 to June 2014) who had indigenous protein rich diet planned by the dietician in the period immediately before the implementation of providing EPA containing protein supplement to the patients. The data was stratified based on gender, age, weight, treatment modalities, stage and site of cancer and analysed using unpaired t test. A p value of < 0.05 was considered significant. The results indicate there was no significant difference in the patient tumor and clinical details. The results indicate that the percent change in weight loss was less in the EPA cohorts when calculated from weight (P < 0.006) and Body Mass Index (BMI) perspective (P < 0.003). Detail analysis suggested that beneficial effects were more in males (P < 0.01), people affected with oral cancer (P < 0.02), people below the age of 40 (P < 0.001), and in people with early stage cancer (P < 0.003). Cumulatively all these results suggest that administering EPA containing protein supplement was effective in arresting weight loss in HNC patients undergoing curative radiotherapy.

Introduction

In many parts of the world, cancer in the head and neck (HN) region is an important ailment [1]. Depending on the anatomical location HNC are termed as cancer of the oral cavity, pharynx, larynx, paranasal sinuses, nasal cavity or salivary glands [2, 3]. Conventionally, surgery is performed when the tumor is in early stage, excisable and the general health of the patient is good; while in advanced condition stage when the cancer has possibly/confirmed to have spread, chemotherapy is the choice of treatment. Radiation, the third most important modality in the management of cancer and is principally the treatment of choice when the tumor is localised, not excisable or when the general health of the patient is not good [2]. Radiation is also used to reduce the size of the tumor before surgery and to eliminate the residual cancer cells that have remained after excision and/or to prevent the possible regrowth/spread. In most cases when the treatment intent is curative, a dose of 60 to 70 Gy is delivered in a prescribed format of 2 Gy fractions for five consecutive days a week for six to seven consecutive weeks without any break in the scheduled plan. Radiation is also combined with low doses of chemotherapy (especially cisplatin/carboplatin) to enhance tumor cell kill and achieve better remission and control [2].

From an anatomical perspective, the HN region is the first site where the digestion starts and its optimal functioning has a very important role in dietary intake for every individual [4, 5]. During the course of the curative radiotherapy, the patient may develop nausea and vomiting, loss of appetite, mucositis, salivary gland changes, xerostomia, dysgeusia, dysphagia, altered taste perception, thickened secretions, inflamed tongue, pain, difficulty in chewing and swallowing [6, 7]. Cumulatively all these adverse events will lead to mild to severe discomfort, difficulties in eating, decreased intake, weight loss and poor morbidity [6, 7]. Realistic appraisals are that the prevalence of weight loss rises to 41–88% of the patients and that it may continue for several weeks in some individuals [4, 8]. Weight loss and under nutrition leads to multiple changes in the body composition and will consequentially affect the physiological process of the body and coexisting lymphopenia worsens it [8]. Very severe weight loss (> 5%) is a major concern as it progressively leads to malnutrition; increases weight loss related morbidity, reduced quality of life, affects the treatment plan, causes treatment break and possibly also impact survival. Malnutrition also effects the recuperation, healing of wound, increase susceptibility to infection and cumulatively all these factors will increase the period of hospitalization [4–7]. There are no indications for severity in weight loss and therefore its prevention/ mitigation with dietary agent during radiation treatment for HNC is important [8].

Eicosapentaenoic acid (EPA), colloquially known as timnodonic acid is an essential fatty acid and found in high concentration in herring, mackerel, salmon, menhaden, sardine, and various edible algae has been reported to provide benefits to individuals afflicted with cardiovascular ailments, aging, and arthritis [9, 10]. Chemically eicosapentaenoic acid contains 20 carbons and five double bonds. It is a type of omega-3 polyunsaturated fatty acid, and is synthesized from α-linolenic acid [11]. EPA is also beneficial in various cancers and to prevent weight loss in gastrointestinal, pancreatic, lung and H&N cancer [12–21]. Mechanistically, EPA is shown to inhibit the production of inflammatory cytokines and the ensuing inflammatory reactions [12–21]. From a mechanistic perspective, scientific studies have shown that EPA modulates the inflammatory response that may contribute to weight loss in cancer. In the recent past EPA containing protein supplements have been marketed and are being prescribed for cancer patients. The current study has been undertaken to ascertain the beneficial effects of EPA containing protein supplement in arresting weight loss in people with H&N cancer undergoing curative radiotherapy.

Methods

This was a retrospective chart review study into people who were diagnosed with cancers in their H&N region and were treated with curative radiotherapy from October 2013 to January 2015 after obtaining approval from the Institutional Review Board (MIO/IEC/2018/02/03). A retrospective chart review was performed for all HNC undergoing curative radiotherapy (62–70 Gy; 2 Gy for five consecutive days a week for 6 to 7 consecutive weeks) with or without low doses of carboplatin (70 mg/m2/day IV) or cisplatin (30 mg/m2/day IV) before radiation treatment using the linear accelerator (Varian Medical systems, USA).

The additional inclusion criteria included patients who were admitted in the hospital inpatient facility throughout the treatment period, did not have any co morbidities (uncontrolled diabetes, hypertension, Chronic Obstructive Pulmonary Disease, Chronic kidney disease), and had a Karnofsky Performance Scale Index of more than 70. Patient’s data was not considered if they received neoadjuvant chemotherapy, had been treated for any other cancer, received altered fractions (hyper/hypo fractionation), or less radiation dose per fraction (< 2 Gy) or sterotactic radiation.

The data from the patient files satisfying the inclusion criteria was extracted by one of the authors (RKD). Information on age, gender, tumor location, histopathology, body mass index (BMI) at the time of diagnosis, changes in the body weight before and after therapy, treatment breaks (the number of days) and the diet information was extracted from the file. The socioeconomic factors and religion were not considered for extraction as all patients admitted in the hospital had equal access to health care and the marginalised patients had complete treatment costs covered by the government insurance. The relative percent weight and BMI change were calculated using the formula: Relative weight change = {[weight at end (kg)-weight at diagnosis (kg)]/weight at diagnosis (kg)} X 100; Relative BMI change = {[BMI at end – BMI at diagnosis]/BMI at diagnosis} X 100.

In the hospital, the patient’s diet plan has been prepared in accordance to the individual’s requirement by a senior dietician considering the local population’s dietary habits and food choice. The breakfast consisted of soft food like idli, dosa, upma, millet/rice stew and soft bread. Depending on their food preference/dietary choice, patients were provided with either vegetable-lentil or chicken soup once a day. The lunch and dinner consisted of rice stew seasoned with cooked vegetables and lentils. In addition to this, as an additional source of protein they were also provided with boiled eggs and milk (at breakfast and dinner).

In July 2014, the senior authors began to prescribe EPA containing protein-rich nutritional supplement Prosure^® (Abbott laboratories, Granada, Spain). The patients were provided with Prosure^® drink prepared by freshly dissolving about 25 g in approximately 120 ml water thrice a day between breakfast and lunch (at around 10.30 am), in the evening (3.30 PM) and half an hour after dinner (8.30 PM)] under the supervision of the oncology nurses. The hospital diet was appropriately modulated by the dietician for every patient to meet the dietary requirements. Patients included in this study were all consecutive cases as described in the inclusion criteria with the help of the MRD in charge. During the time-course of the study, there were no significant changes in the treatment and supportive treatment protocol. As per the standard guidelines followed in the hospital, all the patients were taught to brush their teeth with soft bristled tooth brush and rinse mouth with betadine (10 mL in 100 mL water) solution twice a day. The patients were always provided with the standard oral, dental, medical and supportive care from oncology nurses and physicians.

Statistical Analysis

The data were entered in to Microsoft excel and used for analysis. The data was stratified as to patients who had natural protein diet vs EPA containing protein supplement source throughout the treatment course of 6 to 7 weeks. Descriptive statistics were presented as means and standard deviations for continuous data and as frequency and percentages for dichotomous and categorical data. The data was calculated for the two groups based on the percent changes in the weight and BMI as described in previous section. The data was also stratifying based on BMI (below 18.5 vs above 18.5), age (below 40 vs above 40 years), weight (below 50 vs above 50 kg), gender, site of cancer (oral vs pharyngeal), stage (early vs late), prior surgical status (had surgery vs no surgery) radiation (radiation vs chemo –radiation) and status of treatment breaks and subjected to analysis between the control and EPA containing diet for each of the aspect in consideration. Unpaired t test was used to ascertain the statistical significance between the percent changes in the weight or BMI in the two groups and also in the stratified aspects in the control and EPA groups using the online Vassar stats (http://vassarstats.net/) statistical program. A value p < 0.05 was considered significant.

Results

The information on patient and tumor details is represented in Table 1. The study comprised of 88 people with high protein diet (October 2013 to June 2014) and 53 with EPA containing supplement (from July 2014 to January 2015). The data was not retrieved after February 2015 because of change in the use of mouth gargling solutions that have a role in development of mucositis that affects food intake. Most of the patients were males and the mean age was 54.28 ± 12.71 (Table 1). Cancer of the tongue was the most common in both the groups (Table 1). Most of the patients were in stages 3 and 4 and received chemo-radiotherapy (Table 1). The treatment and other clinical details are all addressed in Table 2.

Table 1.

The gender, age, habits and other demographic details of the patients

Parameters	Groups	Control (N = 88)	EPA containing supplement (N = 53)
	Age	53.89 ± 13.04	54.58 ± 12.00
Sex	Male	62 (70.5%)	39 (73.58%)
	Female	26 (29.5%)	14 (26.42%)
Age	Below 40 years of age	16 (18.18)	17 (32.08)
	Above 40 years of age	72 (81.82)	46 (86.79)
Cancer site	Alveolus	3 (3.4%)	4 (7.56%)
	Base of tongue	1 (1.13%)	0 (0%)
	Buccal mucosa	6 (6.82%)	4 (7.56%)
	Cheek	2 (2.27%)	7 (13.21%)
	Epiglottis	0 (0%)	1 (1.89%)
	Floor of the Mouth	4 (4.54%)	1 (1.89%)
	Hypopharynx	8 (9.09%)	0 (0%)
	Larynx	1 (1.13%)	1 (1.89%)
	Lower lip	1 (1.13%)	0 (0%)
	Maxillary Antrum	1 (1.13%)	2 (3.77%)
	Maxilla	1 (1.13%)	1 (1.89%)
	Nasopharynx	4 (4.54%)	4 (7.56%)
	Oral cavity	10 (11.36%)	1 (1.89%)
	Oropharynx	10 (11.36%)	1 (1.89%)
	Palate (soft & hard)	3 (3.4%)	0 (0%)
	Parotid	0 (0%)	2 (3.77%)
	Pyriform sinus	5 (5.68%)	4 (7.56%)
	Retromolar trigone	1 (1.13%)	3 (5.66%)
	Supraglottis	2 (2.27%)	2 (3.77%)
	Tongue	18 (20.45%)	8 (15.09%)
	Tonsil	4 (4.54%)	2 (3.77%)
	Vocal cord	2 (2.27%)	2 (3.77%)
	Secondary Tumor in neck	1 (1.13%)	1 (1.89%)
	Thyroid	0 (0%)	1 (1.89%)
	GBM	0 (0%)	1 (1.89%)
Site of cancer	Oral cancers	58 (65.91)	39 (73.58)
	Pharyngeal cancers	30 (34.09)	14 (26.42)

Table 2.

The tumor and treatment details in the two groups of patients

Parameters	Groups	Control (N = 88)	EPA containing supplement (N = 53)
Tumor Size (T)	T1	6 (6.82%)	1 (1.89%)
	T2	29 (32.95%)	16 (30.19%)
	T3	31 (35.23%)	22 (41.51%)
	T4	19 (21.59%)	14 (26.42%)
	TX	3 (3.4%)	0 (0%)
Nodes	N0	24 (27.27%)	19 (35.85%)
	N1	26 (29.54%)	21 (39.62%)
	N2	35 (39.77%)	12 (22.64%)
	N3	2 (2.27%)	1 (1.89%)
	NX	1 (1.13%)	0 (0%)
Metastasis	M0	76 (86.36%)	42 (79.25%)
	MX	12 (13.64%)	11 (20.76%)
Stage of cancer	Early stage (T1 + T2)	35 (39.77)	17 (32.08)
	Late stage (T3 + T4)	50 (56.82)	36 (67.92)
BMI	Below 18.5	38 (43.18)	20 (37.73)
	Above 18.5	50 (56.82)	33 (62.26)
Surgical intervention before radiation	Performed	26 (29.54)	15 (28.30)
	Not performed	62 (70.45)	38 (71.69)
Radiation type and dose	Radiation only	27 (30.68%)	19 (35.85%)
	Chemo-radiation	61 (69.32%)	34 (64.15%)
	Radiation dose	67.60 ± 3.6	67.54 ± 3.13
Incidence of treatment breaks	No treatment breaks	58 (65.91)	39 (73.58)
	Treatment breaks	20 (22.72)	18 (20.45)

With regard to weight changes it was observed that EPA supplemented protein had better effect in arresting the reduction when calculated from both BMI as well as weight changes indices (P < 0.006 and P < 0.003; Fig. 1). On a comparative note, administering EPA halted the decrease in weight more effectively in people above the BMI of 18.5 (P < 0.005) (Fig. 1). With regard to gender it was observed that EPA supplemented protein had better effect in males (P < 0.01) than in females (P < 0.08); in people with oral (P < 0.02) than in pharyngeal (P < 0.06) and in people below the age of 40 (p < 0.001) than above 40 (P < 0.026) (Fig. 1).

Fig. 1.

Percent change in BMI and weight when stratified according to age, gender, stage, site of tumor, surgery, radition and treatment break in the control and EPA containing nutritional supplement groups

Administering EPA containing protein supplement was also observed to be effective in arresting weight loss in people with cancer in both early (P < 0.003) and late stage (P < 0.04); in individuals who had surgery (P < 0.05) and no surgery (P < 0.02) prior to radiotherapy; who had radiation only (P < 0.001) and in those who did not have treatment break (P < 0.008) (Fig. 1). Administering EPA was not useful in halting the weight loss in people who had chemo-irradiation (P < 0.22) and treatment breaks (P < 0.115) (Fig. 1). In the study 20 (22.72%) of the control and 18 (20.45%) of the EPA cohorts had treatment break. The principal cause for treatment break was intolerable mucositis and lymphopenia (Fig. 2).

Fig. 2.

Cause for the treatment break in the control and EPA containing nutritional supplement groups

Discussion

Weight loss is a most important and an easy parameter used to describe nutritional status in cancer treatment and care [4, 5, 22]. Reports indicate that in HNC, 20–67% of the patients are malnourished or at high risk of malnutrition at diagnosis and that there is significant weight loss before diagnosis, during treatment and even up-to a year after treatment [7]. To substantiate this, reports have indicated that low initial Karnofsky performance score, use of chemo-radiation and a total dose of > 60 Gy cause significant weight loss during radiotherapy in people afflicted with HNC [23]. Weight loss is also reported to increase morbidity, affect the quality of life and to adversely affect the treatment outcome [24].

In our study it was observed that providing dietary supplement containing EPA was effective in mitigating the percentage decrease when considered from both weight (Fig. 1) and BMI (Fig. 1). These observations are in agreement to the reports of Fietkau and co-workers [25] who have observed that providing enteral nutrition enriched with (EPA) and docosahexaenoic acid (DHA) was effective in preventing weight loss in HNC and oesophageal cancer patients undergoing chemo-radiotherapy [25]. Additionally, recent reports by Mizumachi and co-workers [26], with 17 patients also suggests that providing nutritional supplement with a high blend ratio of w-3 fatty acids was also effective in mitigating chemo-radiation induced oral mucositis and body weight loss in HNC patients [26]. Detailed analysis indicated that when the data was stratified as BMI < 18.5 vs BMI > 18.5 and weight < 50 kg vs weight > 50 kg although EPA reduced the percent decrease significant effects were seen only in the BMI > 18.5 and weight > 50 kg indicating that a differential weight loss change was observable in the people with higher weight/BMI indices and further studies are warranted in this direction.

The observation that overweight or obese people lose significantly more weight than others during the course of cancer treatment was supported by previous studies [22]. In our study, it was observed that when compared to BMI less than 18.5, the weight loss was more in people with BMI above 18.5 (Fig. 1) with possible loss of fat free mass. The other important aspect here with was that providing EPA containing nutritional supplement was more effective in arresting the weight loss in people with BMI more than 20 (P = 0.002), while the same effect was not observed in the cohort where BMI less than 18.5 (P = 0.27) (Fig. 1). The possible reason for this could be that when compared with the people above 18.5 BMI, patients with BMI less than 18.5 have less muscle mass to lose. The other important aspect was that in the study centre enteral nutrition like tube feeding is introduced earlier in patients with BMI less than 18.5 in the hospital to avoid any diet related complications that can interfere with the planned treatment and this could have contributed for the observation.

From a gender perspective, the percent change in weight was more in males (6.64 ± 0.83) than in females (5.5 ± 0.86) and that providing EPA containing nutritional supplement was more effective in arresting the weight loss in men (P = 0.02) than in women (P = 0.08). In the study it was also observed that providing EPA containing nutritional supplement was effective in arresting weight loss in people afflicted with cancer in the oral cavity (P = 0.02) than in the pharyngeal region (P = 0.06). In the treatment of cancer with radiation, the effects are localised and previous reports suggest that patients with oropharyneal tumor had a larger weight loss during the acute phase when compared to patients having tumours of the larynx [22]. Our observations are not in agreement to these reports and this could possibly be because nasogastric feeding is initiated early in people afflicted in with pharyngeal tumours early in our hospital.

With regard to age, in our study it was observed that providing EPA containing nutritional supplement was effective in arresting weight loss in people below and above the age of 40, with statistically significant results being seen in the younger age group (P = 0.001) than in the older (P = 0.026). The possible reason for this difference could be that in the elderly, there is a progressive loss of functional reserves in organs, reduced metabolic and anabolic activities, are more prone to stress and recuperation takes a longer time [27–31] and the possible mechanism must be operating here with. Additionally, the observations also indicated that providing EPA containing nutritional supplement was effective in arresting weight loss in people undergoing treatment in both early (P = 0.003) and late stage cancers (P = 0.04) indicating its usefulness. On a comparative note, percent weight loss was lesser in the early stage cancer and the beneficial effects of EPA were also observed to be better possibly because of better functioning of oral and swallowing structures.

Providing EPA containing nutritional supplement was also effective in arresting weight loss both people who have had undergone surgery (7.56 ± 1.45 in control vs 5.46 ± 1.64 in EPA cohort; P = 0.05) and had no surgery (5.77 ± 0.66 in control vs 4.38 ± 1.02 in EPA cohort; P = 0.02) prior to initiation of radiation therapy (Fig. 1). However, the weight loss was seen to be less in people who had not undergone surgery and this could possibly be due to less morbidity and better HN functioning when compared to the group that had undergone surgery [32–34]. Administering EPA containing nutritional supplement has been shown to increase peri-operative lean body mass in patients with head and neck cancer-related weight loss [35] indicating its usefulness. The results also suggest that EPA containing supplement was effective in radiation alone (5.70 ± 1.02 in control vs 2.81 ± 1.00 in EPA cohort; P = 0.0001), while it was ineffective in the chemo-irradiation group (6.57 ± 0.81 in control vs 5.74 ± 1.06 in EPA cohort; P = 0.2). The possible reason for this could be combining low doses of chemotherapy is known to exacerbate the radiation damage to the oral and swallowing structures, and this could have possibly led for severe side effects, slower anabolic activities and greater weight loss [36–38].

In curative cancer treatment regimen, emphasis is always towards completion of the proposed treatment dose and schedule and at minimising the treatment break. This is because reports have conclusively shown that treatment break can trigger repopulation of the cancer cells, local and distant metastasis all of which have adverse effects on the treatment outcome and affect the survival of the patient [2, 39]. However depending on the inherent radiation sensitivity and the dose of radiation, a individual may develop severe grades of nausea and vomiting, loss of appetite, mucositis, salivary gland changes, dysgeusia, dysphagia, anaemia, lymphopenia and neutropenia which require treatment break [6, 7]. In our study the principal cause for treatment break was intolerable mucositis and lymphopenia (Fig. 2). The most important observation was that when compared to people without treatment break, the patients who had treatment break had greater weight loss and is in agreement to recent reports of Chowdhry and co-workers [40]. The other important observation was that providing EPA containing supplement was effective in arresting radiation induced weight loss only in people who had no treatment breaks [40].

EPA has been studied extensively for its usefulness as an anti-cachexia agent in gastrointestinal, pancreatic, lung and H&N cancer [12–21, 41, 42]. Mechanistic studies are suggestive that the inflammatory mediators like TNF-α, myostatin, and activated protein degradation pathways, trigger/propagate the degradation of muscle protein and thereby accelerate the process of cachexia [43]. Numerous studies carried out in accordance to the tenants of experimental and clinical onco-pharmacology have shown that supplementation of diet or administration of EPA to be improve body mass, appetite and quality of life in people with lean body mass [44]. Studies have also shown that administering EPA improves cisplatin-induced atrophy of muscle without accompanying body weight gain [45]. With regard to HNC, seminal studies by Solís-Martínez and co-workers have shown that administering 2 g/day of EPA to HNC patients decreased serum levels of IL-1β, IL-6, TNF-α, and IFN-γ; reduced the degree of weight loss, lean body mass and body fat mass; and to improve the quality of life [21]. Administering EPA containing nutritional supplement has been shown to increase perioperative lean body mass in patients with head and neck cancer-related weight loss [35] and to prevent weight loss in HNC [25, 26] and oesophageal cancer patients [25] undergoing chemo-radiotherapy. From a mechanistic perspective, administering EPA, which is a known anti-inflammatory agent, is proposed to attenuate cancer cachexia by targeting myriad pathways and inflammatory molecules and needs to be studied in detail using clinical and pre- clinical models of study [12–21, 43].

Conclusions

The notable observation of this study is that the EPA containing supplement was effective in arresting the radiation-induced weight loss in cancer patients undergoing curative radiotherapy and corroborates previous observations [26]. The most important observation in this study is that EPA containing protein supplement was observed to be better in arresting weight loss in people undergoing curative radiotherapy for early (P < 0.003) and late stage (P < 0.04). The drawback of the study is that this is a retrospective study where the control was provided with natural protein source. Studies are also required to understand the effect of EPA supplementation on the inflammatory and anabolic markers in people afflicted with cancer and also when undergoing cytotoxic treatment to bridge the existing lacunae. Within the authors’ admitted limitations, it can be concluded that EPA containing protein supplement has a significant effect in reducing radiation-induced weight loss in people afflicted with HNC and could be of use in clinics.

On a financial view point, currently the 400 g EPA containing protein supplement pack retails in the market for Rs 1170, has a serving size of 9 scoops (75 g) in 240 ml of water. Its label claims to provide approximately 5 servings in each 400 g pack. In HNC patients receiving chemo-radiation therapy over 6 weeks, i.e. 42 days, the doctors or dieticians advice patients to take 1 serving of the EPA containing protein supplement per day, i.e. 9 scoops in 240 ml water or as 2 scoops in 80-100 ml of water, thrice a day, depending on swallowing ability or tolerance. By simple calculation, a patient requires one 400 g pack every 5 days, thus purchasing about 9 boxes by the end of the 6th week. This thus costs the patient about Rs 10,530.00 for 6 weeks, which is expensive for all middle to low income families, in addition to treatment and other miscellaneous expenditures.

The local indigenous health mixes are commonly available in 500 g and 1 kg packs. These packs contain locally available cereals and millets like wheat, red rice, barley, corn, ragi (finger millet), brown top millet, foxtail millet and others, and pulses like green gram, Bengal gram, Horse gram, Urad dal and others in the ratio 70:30 respectively. The cost of these packs range between Rs 216 for 500 g to Rs 396 for 1 kg. The serving size for these local health supplements are 2 tablespoons, i.e. 30 g. In HNC patients receiving chemo-radiation therapy over 6 weeks, i.e. 42 days, the doctors or dieticians advise patients to take 2 servings of the health mix daily. Assuming that a 500 g pack is purchased, a patient requires a pack every 8th day, thus purchasing 6 boxes by the end of the 6th week of treatment. Thus the total expenditure is about Rs 1296 for 6 weeks. Additionally most patients are willing to purchase a pharmaceutical approved omega-3 oil/capsule of Rs 233/ Rs 351 respectively for a prescribed twice a day. The expenditure totals to Rs 1529 or Rs 1647, which is an affordable expense for the patient. However studies to affirm the effectiveness of this combination in preventing weight loss needs to be studied.

Funding

Nil.

Data Availability

The datasets generated during and analysed for the study are available from the corresponding author on reasonable request.

Declarations

Conflict of Interest

There are no conflicts of interest to disclose with respect to the research, authorship, and/or publication of this article.

Ethical Statement

This was a retrospective study ad was conducted after obtaining clearance from Institutional Ethics Committee (MIO/IEC/2018/02/03).

Consent for Publication

All authors consented to the submission of the article for publication to Indian Journal of Otolaryngology and Head & Neck Surgery.

Informed Consent

As this was a retrospective chart based study and did not intervene in any of the therapeutic or patient care procedures followed there was no need of informed consent to be taken and the Institutional ethics committee waived off the requirement.

Research Involving Human Participants

This was a retrospective chart based study on already available data in the hospital and did not include any therapeutic or Psychological intervention. The information present are standard clinical endpoints used in routine clinical practice and especially in oncology to ascertain treatment induced side effects and response and for non-research purposes. The investigators collated the clinical data and analyzed them in this study in accordance to the Indian Council for Medical Research guidelines 2017 for retrospective, non-interventional, chart based studies.