Unspecified Adult Solid Tumor, Protocol Specific
Conditions
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.
Interventions
Given orally
DIETARY_SUPPLEMENTwhite wine
Given orally
OTHERquestionnaire administration
Ancillary studies
Sponsors
National Cancer Institute (NCI)
Academic and Community Cancer Research United
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in the percentage of patients who report an improvement in their appetite over the intervention period | First 3 weeks |
Secondary
| Measure | 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 |
Countries
United States
Outcome results
None listed