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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2009-01130 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| R01CA124614 | U.S. NIH Grant/Contract | View source | |
| RC08C6 | Other Identifier | Mayo Clinic Cancer Center | |
| 09-000862 | Other Identifier | Mayo Clinic IRB |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm A (white wine) | Experimental | Patients consume white wine twice daily for 3-4 weeks. |
|
| Arm B (non-wine nutritional supplement) | Active Comparator | Patients receive an oral non-wine nutritional supplement (e.g., Boost or Ensure) twice daily for 3-4 weeks. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| therapeutic nutritional supplementation | Other | Given orally |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Difference in the percentage of patients who report an improvement in their appetite over the intervention period | First 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Aminah Jatoi, M.D. | Mayo Clinic | Study Chair |
| Tom R. Fitch, M.D. | Mayo Clinic | Principal Investigator |
| Amber L. Isley, M.D. | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Arizona | Scottsdale | Arizona | United States | |||
| Mayo Clinic in Florida |
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| white wine |
| Dietary Supplement |
Given orally |
|
| questionnaire administration | Other | Ancillary studies |
|
| 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 |
| Jacksonville |
| Florida |
| United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Geisinger Medical Center | Danville | Pennsylvania | 17822-2001 | United States |