Clinical trial NCT00936728: White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer
Official title: White Wine for Appetite Loss: A Randomized, Controlled, Non-Blinded Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Lead sponsor: Academic and Community Cancer Research United
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-07-10
Enrollment: 140
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Difference in the percentage of patients who report an improvement in their appetite over the intervention period
timeFrame: First 3 weeks
Secondary outcomes:
measure: Differences in the percentage of patients who manifest weight stability, defined as weight gain of at least 5% of baseline
timeFrame: At one month
measure: Overall survival
timeFrame: Every 6 months for 2 years
measure: Incidence of study intervention-related toxicity
timeFrame: Prior to registration and at week 3-4
measure: Patient-reported quality of life (QOL) as measured by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) appetite scale
timeFrame: Prior to study intervention and then weekly
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Mayo Clinic in Arizona
state: Arizona
city: Jacksonville
country: United States
facility: Mayo Clinic in Florida
state: Florida
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Danville
country: United States
facility: Geisinger Medical Center
state: Pennsylvania
Study officials:
affiliation: Mayo Clinic
name: Aminah Jatoi, M.D.
role: STUDY_CHAIR
affiliation: Mayo Clinic
name: Tom R. Fitch, M.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Amber L. Isley, M.D.
role: PRINCIPAL_INVESTIGATOR
References: