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.
- 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
- 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
Last updated: 05/14/2012
NCT ID: NCT00936728