White Wine for Appetite Loss: A Randomized, Controlled, Non-Blinded Trial
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.
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Difference in the percentage of patients who report an improvement in their appetite over the intervention period
First 3 weeks
No
Aminah Jatoi, M.D.
Study Chair
Mayo Clinic
United States: Federal Government
RC08C6
NCT00936728
July 2009
Name | Location |
---|---|
Mayo Clinic | Rochester, Minnesota 55905 |
Mayo Clinic in Arizona | Scottsdale, Arizona 85259-5404 |
Mayo Clinic in Florida | Jacksonville, Florida 32224 |