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

21 Years
Open (Enrolling)
Unspecified Adult Solid Tumor, Protocol Specific

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Trial Information

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


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

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

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Difference in the percentage of patients who report an improvement in their appetite over the intervention period

Outcome Time Frame:

First 3 weeks

Safety Issue:


Principal Investigator

Aminah Jatoi, M.D.

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

July 2009

Completion Date:

Related Keywords:

  • Unspecified Adult Solid Tumor, Protocol Specific



Mayo Clinic Rochester, Minnesota  55905
Mayo Clinic in Arizona Scottsdale, Arizona  85259-5404
Mayo Clinic in Florida Jacksonville, Florida  32224