White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer
Study Details
Study Description
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
Condition or Disease | Intervention/Treatment | Phase |
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|
N/A |
Detailed Description
OBJECTIVES:
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To compare white wine (Arm A) to non-wine nutritional supplement (Arm B) for the treatment of cancer-associated anorexia.
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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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Arm A (white wine) Patients consume white wine twice daily for 3-4 weeks. |
Dietary Supplement: white wine
Given orally
Other: questionnaire administration
Ancillary studies
|
Active Comparator: Arm B (non-wine nutritional supplement) Patients receive an oral non-wine nutritional supplement (e.g., Boost or Ensure) twice daily for 3-4 weeks. |
Other: therapeutic nutritional supplementation
Given orally
Other: questionnaire administration
Ancillary studies
|
Outcome Measures
Primary Outcome Measures
- Difference in the percentage of patients who report an improvement in their appetite over the intervention period [First 3 weeks]
Secondary Outcome Measures
- 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
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Incurable, invasive malignancy
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Able to reliably take the study intervention as prescribed in this protocol
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No prior or current history of alcoholism
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Alert and mentally competent
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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)
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Patient perceives loss of appetite and/or weight as a problem; NOTE: Documentation not necessary
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Concurrent chemotherapy and/or radiotherapy are permitted
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Negative pregnancy test done =< 7 days prior to registration, for women of childbearing potential only
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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
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Ability to complete questionnaire(s) by themselves or with assistance
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Willingness to return to MCCRC enrolling institution for follow-up
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Patients in whom the use of progestational agents is anticipated are not permitted to be on this study
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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:
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Receiving tube feedings or parenteral nutrition
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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
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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
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Known mechanical obstruction of the alimentary tract, malabsorption, or intractable vomiting (> 5 episodes/week)
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Symptomatic or untreated brain metastases
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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
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Mayo Clinic in Arizona | Scottsdale | Arizona | United States | |
2 | Mayo Clinic in Florida | Jacksonville | Florida | United States | |
3 | Mayo Clinic | Rochester | Minnesota | United States | 55905 |
4 | Geisinger Medical Center | Danville | Pennsylvania | United States | 17822-2001 |
Sponsors and Collaborators
- Academic and Community Cancer Research United
- National Cancer Institute (NCI)
Investigators
- Study Chair: Aminah Jatoi, M.D., Mayo Clinic
- Principal Investigator: Tom R. Fitch, M.D., Mayo Clinic
- Principal Investigator: Amber L. Isley, M.D., Mayo Clinic
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- RC08C6
- NCI-2009-01130
- R01CA124614
- RC08C6
- 09-000862