Table 4.
Author, year of publication | Intervention | Healthcare professional that provides the intervention | Comparison | Adherence | Dropout reasons | Results |
---|---|---|---|---|---|---|
Hopkinson, 2010 | Support offered by MAWE-trained clinical nurse specialists. The components of MAWE are “breaking through the weight loss taboo”, “telling healing stories”, “managing conflict”, “support for eating well”, and “support for self-action”. These components are delivered during home consultations between nurse, patient, and caregiver. Delivery is supported by a pack of information leaflets entitled “Living with Changes in Eating”. |
Nurse | Usual care | 50/65 (77%) IG 25/35 (71%) CG 25/30 (83%) |
Death (n = 7) A decline in clinical condition (n = 4) Discharge (n = 1) Another reason unrelated to the study (n = 3) |
The intensity of eating- and weight-related distress was greater in the control group than that in the MAWE group. From the qualitative analysis: The thematic and content analysis found that MAWE was perceived as helpful by 1) supporting eating well with advanced cancer and 2) supporting self-management. |
Faber, 2015 | Dietary counseling +2 doses (2 × 200 mL sip feed) of active medical food for patients in the 0–5% WL group and at least 2 doses for patients in the ≥ 5% WL group. Active medical food is an energy-dense (163 kcal/100 mL), nutritionally complete oral supplement (FortiCare) that is high in protein and leucine (9.9 g protein/100 mL and 1.1 g free leucine/100 mL) and is enriched with emulsified fish oil (0.6 g EPA and 0.3 g DHA/100 mL), specific oligosaccharides (1.2 g galactooligosaccharides and 0.2 g fructooligosaccharides/100 mL) and a balanced mix of vitamins, minerals, and trace elements. | Not described | Dietary counseling +2 doses (2 × 200 mL sip feed) of the Control product daily for patients in the 0–5% WL group and at least 2 doses for patients in the ≥ 5% WL group. The Control product is for the 0–5% WL group, a non-caloric placebo product, and for the ≥ 5% WL group, an energy-dense (163 kcal/100 mL) iso-caloric standard nutritional product. | 24/31 in the IG (77%). 23/33 in the CG (70%). Compliance (> 75% of the minimum amount of product): IG 89% and CG 87% |
Start treatments 8/64, adverse event 2/64, withdrew consent 1/64, disease progression 1/64, other reasons 5/64 | After 4 weeks, no differences regarding:
|
Focan, 2015 | Standard cachexia management + mindfulness and diet workshops (4 double workshops every 2 weeks) for a maximum of 10 patients conducted alternatively by psychologists and dieticians. In the diet workshops, foods had to be appraised through the five senses. Enrichment techniques and tasting of dishes at the level of the taste, the sense of smell, and the texture (touch) were developed. |
Psychologist and dietitian | Standard cachexia management (standard dietetic support and eventual nutritional supplements according to estimated patient needs). | 12/28 (43%) intervention group Adherence in the control group was not declared. |
Not declared. | Significant increase of:
No significant differences with regard to biological parameters, quantitative or relative qualitative calorie intakes, or nutritional indices. |
Grundmann, 2015 and Yoon, 2015 | Acupuncture treatment was administered by a qualified acupuncturist at his private practice. The intervention was provided to participants once prior to chemotherapy, once per week for 1 h between chemotherapy cycles, and once after chemotherapy. The total number of acupuncture treatments per participant was eight sessions during about eight weeks, which covered up to two chemotherapy cycles. The standards for reporting interventions in Clinical trials of acupuncture (STRICTA) recommendations were used as a guideline. All subjects received the same primary acupuncture points, including both auricular and body acupuncture points. Each participant received additional acupuncture interventions, which consisted of secondary acupuncture points, to address any specific symptoms that occurred to participants during the study and affected weight loss as well as appetite. |
Acupuncturist | Not applicable | 7/7 patients completed the intervention (100%) | Not applicable |
Results from BIA Stability in:
Increase in:
|
Kapoor, 2017 | 30 min of dietary counseling by a qualified nutritionist +100 g of IAtta, to be consumed every day in addition to their daily dietary intake for 6 months. Patients collected 14 packets of IAtta every fortnight during their appointments. Each 100 g of IAtta contained a mixture of roasted bengal gram flour, roasted barley flour, roasted soybean flour, flaxseed powder, and dried Amaranthus spinosus powder. The caregiver was advised to make unleavened flat breads (chapatis). On average 3 flat breads could be prepared from each pack, which provides approximately 400 kcal. Each 400 kcal consists of 50% daily protein requirement, 75% daily fat requirement, and 30%–50% of iron, calcium, and vitamin A. |
Nutritionist | 30 min of dietary counseling by a qualified nutritionist (twice a month). Patients were advised to increase the frequency of homemade meals and encouraged to consume energy- and protein-dense food products. Depending on the physical status of the patients, low levels of physical activity (walking and/or stairs) and participation in household activities were encouraged during counseling sessions. | 33/63 patients (52%) completed the final follow-up at 6 months: 17/30 in the IG (57%) and 15/33 in the CG (45%). | Dropout causes were death (13 pts, four in CG and nine in IG) and loss to follow-up due to traveling difficulties, being bedridden or financial problems (18 pts, 14 in CG and four in IG). No demographic or clinical differences among the patients who dropped out compared with the ones who finished the study. | In the IG:
|
Parmar, 2017 | The multimodal interventions offered by the CNR-JGH clinic consisted of:
|
Physician, nurse, physiotherapist and dietitian. | Not applicable | QoL scores were obtained from over 90% of patients at each clinic visit. Only 42% of the original cohort remained at visit 3. The proportion of dropouts between visit 1 and visit 3 was 50%–66%. |
|
Consistent and statistically significant improvements in FAACT total (Visit1-3 +7.3), TOI (Visit1-3 +7.7), physical (Visit1-3 +2.3), and cachexia (Visit1-3 +4.1) subscales, over each visit interval, but not for the social and emotional subscale. Even though features such as being female, having GI cancer, high symptom scores, and poor performance status were associated with poorer QoL scores, the presence of these features at visit 1 did not preclude the possibility of improvements in QoL during the period of the clinical intervention. The greatest benefits of QoL were seen in those patients who gained weight and improved their 6 MWT. |
Grundmann, 2019 and Yoon, 2019 | Eight weekly acupuncture sessions of 45–50 min in consecutive weeks, provided by a certified acupuncturist. The selected 23 auricular and body acupuncture points (same for each patient) were linked to specific biological factors that affect the processes involved in the initiation, progression, or maintenance of cachexia (anti-inflammatory/immunomodulation, stress/autonomic nervous system, anorexia, and muscle wasting) using auricular acupuncture and traditional Chinese medicine. All the targeted points were needled with the patients fully dressed and in a supine position. Acupuncture needles were single-use, sterile stainless steel, and disposable, measuring 0.20 × 15 mm or 0.20 × 30 mm. The auricular points were located using their standard anatomical location and needled at proper needling depth (0.5–1.5 cm) bilaterally. Needles were retained for 15–20 min followed by the application of manual stimulation with an even rotating method until the needling (de qi) sensation or needle grasp sensation was obtained. |
Acupuncturist | Eight weekly acupuncture sessions of 45–50 min in consecutive weeks, provided by a certified acupuncturist. Needles were applied to 5 acupuncture points that were not specific to the mechanisms of cachexia (headache, sore throat, or nasal congestion). |
30 patients (79%) completed the 8-week intervention (attrition rate of 21%) IG: 15/20 (75%) CG: 15/18 (83%) |
The reasons for withdrawal from the study after the first treatment were primarily related to extra transportation arrangements and decreased interest in the study. Of the two patients completing five treatments, one was dropped by the research team due to a protocol violation, while the other withdrew for personal reasons. | Increase in:
A decrease in leptin in the male intervention (MI) group corresponded to higher appetite and weight gain. The elevated ECW/ICW ratio indicated an inflammatory response in the MI group. |
Yuliatun, 2019 | Eight 30-min sessions of manual acupuncture were performed every two days by a certified acupuncturist. Acupuncture needles were single-use, sterile stainless steel, and disposable, a brand of Huan Qiu made in China measuring 0.25 × 25 mm for acupuncture points Hegu (LI-4), Zusanli (ST36), Sanyinjiao (Sp6), Xuehai (Sp10), Neiguan (P6) and Dazhui (GV14), and needle size 0.13 × 20 mm for acupuncture point of dicang (ST4). Acupuncture points were located using standard anatomical location and needle at proper needling depth (0.5–1.5 cm) bilaterally. | Acupuncturist | Not applicable | 7/7 patients completed the intervention (100%) | Not applicable | Body weight, BMI, and FFM did not significantly change during the study. 11.63% of patients had a body weight decrease at the end of the intervention. 19.4% of patients had a BMI decrease at the end of the intervention. |
Kamel, 2020 | Progressive resistance training, achieved through 60-min machine-based exercise sessions carried out twice a week for 12 weeks. Groups of one to four patients underwent the sessions at a time, supervised by specialized physical therapists. At each session, general flexibility exercises and one set for the first exercise of upper and lower extremities were performed before the training program at a lower training intensity, to ensure adequate warm-up. Machine-based resistance exercises followed the warm-up. Following two familiarization sessions, one to two sets of the first five exercises with 20 repetitions were performed by participants for a four-week adjustment phase of low to moderate intensity (50%–60% 1-RM). Beginning at week 5, the number of exercises was increased to eight per session; the patients were asked to perform three sets with 8–12 repetitions, with a moderate to high frequency (60%–80% 1-RM). In case of clinical complications (e.g., infections, fever, high or low blood pressure, etc.), resistance training was stopped immediately. Participation in the study could be interrupted at any moment by the oncologist or the patient him/herself. |
Physiotherapist | Nutritional and psychosocial support, no exercise regimen. The physiotherapist contacted the patients once a month by phone to inquire about the possible negative outcomes of cancer therapy. |
33/40 patients completed the study (83%): 17/20 (85%) in the IG and 16/20 (80%) in the CG. | Dropout causes were death (n = 2; 1 IG,1 CG), withdrawal (n = 3; 2 IG, 1 CG) and disease progression (n = 2; 2 CG). | Significant increase in:
|
Latenstein, 2020 | Dietetic consultation | Dietitian | Not applicable | Not applicable | Not applicable |
Patients who underwent surgery
|
Bland, 2021 | When patients with cancer presented involuntary weight loss, anorexia symptoms, and/or functional declines, they were referred to the clinical service and screened and triaged over the phone by a nurse practitioner. At the first visit, patients and caregivers met with the entire multidisciplinary care team for 80 min. The care team included a palliative medicine physician, nurse practitioner, dietitian, and physiotherapist. With shared decision-making, the multidisciplinary care team formulated an individually tailored multimodal treatment plan, which could include drugs for symptoms, nutritional counseling (diet advice and oral nutritional supplements), and physiotherapy advice (home-based exercise). Follow-up visits lasted approximately 40 min and occurred every four to six weeks. |
Palliative medicine physician, nurse practitioner, dietitian, and physiotherapist | Not applicable. | Not applicable. | 101 (62%) patients died at follow-up (not specified if visit 2 or 3). | No significant main change in body weight (P = 0.907), hand-grip strength (P = 0.734), and 30s sit-to-stand (P = 0.133) occurred over time. Significant improvements in overall QoL (P < 0.001), physical function (P < 0.003), and emotional function (P < 0.001) were detected between the first and second visits. Results were maintained at the third visit. Significant main effects were also found for all EORTC QLQ-C15-PAL symptoms, except for constipation (P = 0.078), insomnia, and breathlessness. FAACT outcomes improved between the first and second visit (FAACT total score P < 0.001, the FACT-G total score P < 0.001, the TOI P < 0.001, anorexia-cachexia symptoms P < 0.001, physical P < 0.001, emotional P = 0.005, and functional wellbeing P = 0.001), and they remained stable after the third visit. |
Molassiotis, 2021 | The intervention provided three structured sessions (2–3 h) of dietitian direct contact time over a 4-week period, inclusive of telehealth (Australian site only) or telephone follow-ups to monitor, reinforce and adjust goals. The context of the intervention was around nutrition impact symptoms, quality of life and food or eating-related psychosocial concerns in patients and caregivers through nutrition counselling, as well as addressing nutrition-related communication between the dyads, rather than solely achieving sufficient energy/protein intake, which is a common approach in traditional dietary interventions. The intervention also included a culturally adapted booklet that was provided to the patients and their caregivers. If patients were admitted to the hospital during the intervention period, the ward dietitian provided dietetic care to the patient while they were an inpatient, and the research dietitian continued with the intervention following discharge. |
Dietitian | Subjects in the control group received the usual care, which may have involved some nutrition advice and symptom management. More specifically, in Hong Kong usual care involved nutritional advice and symptom management by the palliative care team in the hospitals. Referral to a dietitian was offered when medically indicated by physicians. An assessment was usually conducted every 4–6 weeks, depending on whether the patient achieved improvements in dietary intake. Following completion of outcome assessments, patients were given the option to participate in intensive dietitian-delivered nutrition counseling off the trial. |
Recruitment feasibility 22/34 (64.7%) patients in the IG group completed the intervention vs 30/40 (75%) in the CG. 17 patients in the IG group completed the week 5 assessment vs 21 patients in the CG. |
Dropout reasons were withdrawal (n = 5), unable to complete within the study timeframe (n = 1), re-hospitalized (n = 3), passed away n = 10, no mood (n = 3). |
Acceptability of assessment tools The assessment tools used were generally acceptable, with a rating ≥ 5.18 (on a 0–10 point scale) in both sites. Outcome assessments Results showed a tendency for improvements in all patient outcome measures in IG compared with CG. These changes reached statistical significance (P < 0.05) for Eating-related distress and FAACT QoL, in the Australian sample, and Eating-related enjoyment, in the Hong Kong sample. Caregiver outcome measures showed a smaller and not statistically significant difference in all variables between IG and CG. Weight was maintained in the IG and decreased slightly in the CG. Clinically significant improvements were observed in the IG in terms of mean energy intake and mean protein intake. |
Sim, 2022 | The experimental group received regular nutrition counseling and education. Patients in IG were asked to take ONS twice a day (400 mL, 400 kcal). Patients were asked to record the amounts of ONS consumed, and weekly telephone counseling was used to determine and maintain compliance. ONS was a product enriched with omega-3 fatty acids (70 mg/200 mL) and arginine (250 mg/200 mL). |
Dietitian | In addition to nutritional counseling and education, patients in the control group also received a weekly telephone call from a trained dietitian for further nutrition counseling. | 40 patients (69%) concluded the study and were included in the final analyses (22 patients in the IG [55%], 18 patients [67%] in the CG). | nine patients dropped out in the IG (n = 3 death, n = 1 transfer, n = 1 no specific reason, n = 4 included in other studies). nine patients dropped out in the CG (n = 2 death, n = 2 transfer, n = 2 nausea, n = 1 poor condition, n = 2 no specific reason). |
Nutritional status – PG-SGA scores The paired t test between week 0 and week 8 showed improvements in both groups; only in the IG, the results were statistically significant (P = 0.001). No differences were detected between IG and CG (P = 0.118). Quality of life score - EORTC-QLQ C30 The global health status score was increased only in the IG, but no differences were detected between IG and CG. Among functional scales, the role function score was significantly decreased in the CG (P = 0.001) at week 8, while that of the IG did not change. Fatigue, nausea and vomiting, and all other symptom scales showed a steady decrease in the IG and a steady increase in the CG, between baseline and week 8. Biochemical markers No significant difference between groups was observed, and the concentration of inflammatory cytokines also did not exhibit any differences. |
Bagheri, 2023 | All patients were visited by expert dietitians, who prescribed a Mediterranean diet regime with extra virgin olive oil (EVOO) only for the IG group. For the Mediterranean diet group, the required energy for the patients was estimated according to the ASPEN guidelines, which started with 25 kcal/kg body weight per day and then reached 35 kcal/kg body weight per day within two weeks. The weekly dietary menu was designed according to the Mediterranean regimen, and EVOO was provided free of charge to the patients during the intervention period. Moreover, for the convenience of the patients and to increase their adherence to the protocol, the diet was personalized based on their tastes. The duration of the intervention was eight weeks. |
Dietitian | All patients were visited by expert dietitians. In the control group, routine According to the clinical guidelines, nutritional recommendations regarding weight gain and prevention of weight loss in cancer patients were given as brochures. |
40/46 (86.9%) 46 patients entered the randomization stage, and 40 patients completed the study. |
In the IG: N = 2 did not complete the study N = 1 did not follow the diet. In the CG: N = 2 did not complete the study N = 1 died. |
Anthropometric indices Average weight (changes from baseline in IG 0.94 vs −1.81, P = < 0.001), lean body mass (IG vs CG: 0.35 vs −1.35, P = 0.01), fat mass (IG vs CG: 0.76 vs −0.58, P = 0.002), fat percentage (IG vs CG: 0.98 vs −0.78, P = 0.02) and muscle strength (IG vs CG: 1.56 vs −2.29, P < 0.001) significantly increased in IG. Quality of life PG-SGA score decreased significantly (IG vs CG: −4.04 vs 1.86, P < 0.001), showing the improved nutritional status in the Mediterranean diet group. In IG the score for global health status (IG vs CG: 6.78 vs −3.95, P = 0.02), physical performance score (IG vs CG: 8.44 vs −6.32, P < 0.001), appetite (IG vs CG: −6.67 vs 13.29, P = 0.01), and diarrhea (IG vs CG: −2.14 vs 15.48, P = 0.02) were improved significantly. Inflammatory markers The mean serum level of TNF-α was significantly decreased in the Mediterranean diet group (IG vs CG groups: −0.47 vs 0.35, P < 0.001). The mean serum levels of hs-CRP (IG vs CGs: −63.23 vs 1,406.62, P = 0.01) and IL-6 (IG vs CG: −0.02 vs 1.09, P < 0.001) were significantly increased in the control group. The average of total serum protein in the CG was significantly decreased compared to IG (IG vs CG: 0.04 vs −0.46, P = 0.008). |
Buonaccorso, 2023 | The intervention included psycho-educational and rehabilitative interventions in addition to standard care. The psycho-educational component of the intervention included three weekly meetings for dyads led by three trained nurses. The face-to-face consultations aimed to help the dyad cope with involuntary weight loss and declining appetite by seeking to strengthen individual and dyadic coping resources. The dyads were given an information booklet, which included a description of cancer cachexia and the major emotional reactions of patients and families. The rehabilitative component of the intervention was conducted by two trained physiotherapists. It included three individual outpatient sessions in two months and three home sessions of exercises per week, carried out by the patient on his or her own or with the help of the caregiver, for a total of at least 24 home sessions +3 outpatient face-to-face meetings with the physiotherapists over eight weeks. |
Nurse and physiotherapist | The standard care was a specialized PC visit. | Twenty-four dyads were evaluated at baseline (T0), sixteen (66.6%) at T1, 11 (45.8%) at T2, and six (25%) at T3 final follow-up. 20/24 dyads completed the psychoeducational component, which was feasible for 83.3% of the sample. 6/24 dyads completed the rehabilitative component, which was feasible for 25% of the sample. |
18/24 patients withdrew from the study:
12/24 patients (50%) died within three months of enrollment. |
QoL decreased over time, and the caregiver burden diminished between enrollment and T2. Upper limb strength was substantially stable in the first month (between T0 and T2) and worsened at T3. Lower limb physical performance measured by the 30-s sit-to-stand test showed better scores at T3. Considering the scores of patients evaluated at two months follow-up (T3), the trend showed no deterioration in QoL, caregiver burden, or patients' physical performance. Qualitative data from six interviews showed a good level of acceptability of the bimodal intervention. |
MAWE, Macmillan Approach to Weight and Eating; IG, intervention group; CG, control group; WL, weight loss; EPA, eicosatetraenoic acid; DHA, docosahexaenoic acid; PBMC, blood peripheral mononuclear cells; QoL, Quality of Life; PS, performance status; BMI,: body mass index; BIA, bioelectrical impedance analysis; SNAQ, Simplified Nutritional Appetite Questionnaire; KPS, Karnofsky Performance Scale; PG-SGA, Patient-Generated Subjective Global Assessment; MET, metabolic equivalent unit; MUAC, mid-upper arm circumference; FAACT scale, Functional Assessment of Anorexia/Cachexia Treatment Scale; TOI, Trial Outcome Index; MWT, minute walking test; FFM, fat-free mass; ECW, extracellular water; ICW, intracellular water; RM, repetition maximum; EORTC QLQ-C15-PAL, EORTC Quality of Life Questionnaire Core 15 Palliative Care; ONS, oral nutritional supplement.