Status:
COMPLETED
White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer
Lead Sponsor:
Academic and Community Cancer Research United
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Unspecified Adult Solid Tumor, Protocol Specific
Eligibility:
All Genders
21+ years
Phase:
NA
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 ...
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)...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 17 2017
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT00936728
Start Date
July 1 2009
End Date
April 17 2017
Last Update
February 1 2023
Active Locations (4)
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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