Kapoor, N., Naufahu, J., Tewfik, S., Bhatnagar, S., Garg, R., & Tewfik, I. (2016). A prospective randomized controlled trial to study the impact of a nutrition-sensitive intervention on adult women with cancer cachexia undergoing palliative care in India. Integrative Cancer Therapies. Advance online publication. 

To assess the efficacy of a whole wheat flour mix along with local ingredients (IATTA) with counseling to enhance dietary intake, physical activity, and quality of life (QOL)

Patients in the intervention group received 14 packets of IATTA every two weeks during appointments along with 30 minutes of counseling by a qualified nutritionist at each visit. They were advised to eat the contents of one whole packet along with their daily diet. Physical activity, such as walking, was also encouraged during counseling sessions. Patients in the control group received 30 minutes of counseling only by a qualified nutritionist at each visit.

• N = 63 (30 in intervention group and 33 in control group)
• MEDIAN AGE = 44 years (intervention group), 47.8 years (control group)
• FEMALES: 100%
• CURRENT TREATMENT: Chemotherapy, radiation, combination radiation, chemotherapy
• KEY DISEASE CHARACTERISTICS: Loss of more than 5% from pretreatment, body mass index less than 20 kg/m², hemoglobin less than 12g/dl, energy intake less than 1,500 kcl/d 
• OTHER KEY SAMPLE CHARACTERISTICS: Exclusions: Patients with gastrointestinal disorders who were on anabolic steroids, taking synthetic oral supplements, and/or had a life expectancy of less than three months

• SITE: Single site   
• SETTING TYPE: Outpatient    
• LOCATION: India

• PHASE OF CARE: Active antitumor treatment
• APPLICATIONS: Palliative care 

• Prospective, randomized, controlled trial

Anthropometric measurements of nutritional status, physical activity, and QOL measurements:

• Body weight
• Mid-upper arm circumference (MUAC)
• Dietary questionnaire: Patient Generated Subjective Global Assessment
• Physical activity questionnaire: Indian Migrant Study Physical Activity Questionnaire
• QOL assessment: European Organization for Research and Treatment of Cancer (EORTC) Quality of Life (QLQ-C30) questionnaire

Fifty-one percent of patients completed the study. Patients in the intervention group tended to gain weight, but it was not statistically significant. Patients in the control group showed statistically significant weight loss (p = 0.003) and reduced MUAC (p = 0.006). Body fat increased significantly in the intervention group (p = 0.002) and decreased significantly in the control group (p = 0.032) at the end of the six-month intervention period from baseline. At the end of six months, significant energy intake increased in the intervention group (p = 0.001) with carbohydrates (p = 0.001), protein (p = 0.001), and fat (p = 0.006), respectively. Physical activity recall showed significantly reduced activity in the control group (p = 0.004). Patients in the intervention group did not show a change in physical activity. The intervention group showed a statistically significant improvement in QOL in factors such as fatigue (p = 0.002) and appetite loss (p = 0.006). The control group showed a statistically significant decrease in the domains of global health status (p = 0.018) and social functioning (p = 0.004). At the end of six months, global health status, social functioning, appetite, and fatigue showed significant differences between the two groups (p < 0.001).

Nutrition therapy and supplementation within palliative care may improve QOL and stabilize weight in patients with cancer and cachexia. Nearly 50% of patients did not complete the study, so further study is indicated.

• Small sample (< 100)
• Risk of bias (sample characteristics)
• Key sample group differences that could influence results
• Findings not generalizable
• Subject withdrawals ≥ 10%  
• Female patients only
• Homogeneous population—not diverse

Nutrition counseling is imperative through all phases of cancer care. Further study of nutrition counseling and intervention should include QOL measures, such as physical activity, social functioning, and pain status.