Trials / Completed
CompletedNCT00936728
White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer
White Wine for Appetite Loss: A Randomized, Controlled, Non-Blinded Trial
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 140 (estimated)
- Sponsor
- Academic and Community Cancer Research United · Academic / Other
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
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
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | therapeutic nutritional supplementation | Given orally |
| DIETARY_SUPPLEMENT | white wine | Given orally |
| OTHER | questionnaire administration | Ancillary studies |
Timeline
- Start date
- 2009-07-01
- Primary completion
- 2017-03-02
- Completion
- 2017-04-17
- First posted
- 2009-07-10
- Last updated
- 2023-02-01
Locations
4 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00936728. Inclusion in this directory is not an endorsement.