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