White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer

Study Overview
=================
Brief 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.

Official Title
-----------------
White Wine for Appetite Loss: A Randomized, Controlled, Non-Blinded Trial

Conditions
-----------------
Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
-----------------
* Other: therapeutic nutritional supplementation
* Dietary Supplement: white wine
* Other: questionnaire administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Incurable, invasive malignancy Able to reliably take the study intervention as prescribed in this protocol No prior or current history of alcoholism Alert and mentally competent Physician estimates that patient has lost >= 5 pounds (2.3 kg) in weight =< 2 months (excluding peri-operative weight loss; documented weight loss not required) and/or have estimated caloric intake of < 20 cal/kg daily (no further documentation necessary other than an affirmative answer to this statement) Patient perceives loss of appetite and/or weight as a problem; NOTE: Documentation not necessary Concurrent chemotherapy and/or radiotherapy are permitted Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only Willingness to abstain completely from alcohol for 4 weeks, except as prescribed in this trial; NOTE: Patients assigned to the non-wine nutritional supplement (Arm B) must be willing to abstain from wine and other alcoholic beverages for 3-4 weeks; Patients assigned to the white wine (Arm A) are allowed to take a nutritional supplement, such as Ensure or Boost if they choose to Ability to complete questionnaire(s) by themselves or with assistance Willingness to return to MCCRC enrolling institution for follow-up Patients in whom the use of progestational agents is anticipated are not permitted to be on this study Short-term use of dexamethasone around days of intravenous chemotherapy is allowed for protection against emesis, but dexamethasone for appetite stimulation is not permitted Exclusion Criteria: Receiving tube feedings or parenteral nutrition Current (=< 1 month) or planned treatment with adrenal corticosteroids (short-term use of dexamethasone around days of chemotherapy is allowed for protection against emesis), androgens, or progestational agents; EXCEPTION: Inhalant, topical, or optical steroid use is permissible Progestational agent (such as megestrol acetate) planned to be initiated over the next 30 days; NOTE: Patients who have been on megestrol acetate for > 1 month and are still on it and otherwise meet the eligibility criteria are permitted to enroll on this protocol and remain on megestrol acetate Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (> 5 episodes/week) Symptomatic or untreated brain metastases Any of the following as this regimen may be harmful to a developing fetus or nursing child: pregnant women, nursing women, and men or women of childbearing potential who are unwilling to employ adequate contraception

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm A (white wine)<br>Patients consume white wine twice daily for 3-4 weeks. | Dietary Supplement: white wine<br>* Given orally<br>Other: questionnaire administration<br>* Ancillary studies<br>|
| Active Comparator: Arm B (non-wine nutritional supplement)<br>Patients receive an oral non-wine nutritional supplement (e.g., Boost or Ensure) twice daily for 3-4 weeks. | Other: therapeutic nutritional supplementation<br>* Given orally<br>Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the percentage of patients who report an improvement in their appetite over the intervention period |  | First 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in the percentage of patients who manifest weight stability, defined as weight gain of at least 5% of baseline |  | At one month | 
| Overall survival |  | Every 6 months for 2 years | 
| Incidence of study intervention-related toxicity |  | 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 |  | Prior to study intervention and then weekly |