RATIONALE: It is not yet know whether white wine is more effective than a nutritional supplement in improving appetite. PURPOSE: This randomized clinical trial is studying white wine to see how well it works compared with a nutritional supplement in improving appetite in patients with cancer
OBJECTIVES: I. To compare white wine (Arm A) to non-wine nutritional supplement (Arm B) for the treatment of cancer-associated anorexia. II. To evaluate the side effect profile of white wine (Arm A). OUTLINE: Patients are stratified according to primary malignant disease (lung vs gastrointestinal vs other \[specify\]), severity of weight loss (excluding peri-operative weight loss) within the past 2 months (\< 4.6 kg \[\< 10 lbs\] vs \>= 4.6 kg \[\>= 10 lbs\]), age (\< 50 years vs \>= 50 years), and planned concurrent chemotherapy or radiation (yes vs no). Patients are randomized to 1 of 2 arms. ARM A: Patients consume white wine with =\< 15% alcohol content twice daily for 3-4 weeks. ARM B: Patients receive an oral non-wine nutritional supplement (e.g., Boost or Ensure) twice daily for 3-4 weeks. After completion of study treatment, patients are followed up every 6 months for 2 years.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
140
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
Mayo Clinic in Florida
Jacksonville, Florida, United States
Mayo Clinic
Rochester, Minnesota, United States
Geisinger Medical Center
Danville, Pennsylvania, United States
Difference in the percentage of patients who report an improvement in their appetite over the intervention period
Time frame: First 3 weeks
Differences in the percentage of patients who manifest weight stability, defined as weight gain of at least 5% of baseline
Time frame: At one month
Overall survival
Time frame: Every 6 months for 2 years
Incidence of study intervention-related toxicity
Time frame: Prior to registration and at week 3-4
Patient-reported quality of life (QOL) as measured by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) appetite scale
Time frame: Prior to study intervention and then weekly
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