White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00936728
Recruitment Status : Active, not recruiting
First Posted : July 10, 2009
Last Update Posted : February 6, 2018
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Mayo Clinic

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
Unspecified Adult Solid Tumor, Protocol Specific Other: therapeutic nutritional supplementation Dietary Supplement: white wine Other: questionnaire administration Not Applicable

Detailed Description:


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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: White Wine for Appetite Loss: A Randomized, Controlled, Non-Blinded Trial
Actual Study Start Date : July 2009
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Primary Outcome Measures :
  1. Difference in the percentage of patients who report an improvement in their appetite over the intervention period [ Time Frame: First 3 weeks ]

Secondary Outcome Measures :
  1. Differences in the percentage of patients who manifest weight stability, defined as weight gain of at least 5% of baseline [ Time Frame: At one month ]
  2. Overall survival [ Time Frame: Every 6 months for 2 years ]
  3. Incidence of study intervention-related toxicity [ Time Frame: Prior to registration and at week 3-4 ]
  4. Patient-reported quality of life (QOL) as measured by the Functional Assessment of Anorexia/Cachexia Therapy (FAACT) appetite scale [ Time Frame: Prior to study intervention and then weekly ]

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00936728

United States, Arizona
Mayo Clinic in Arizona
Scottsdale, Arizona, United States
United States, Florida
Mayo Clinic in Florida
Jacksonville, Florida, United States
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Pennsylvania
Geisinger Medical Center
Danville, Pennsylvania, United States, 17822-2001
Sponsors and Collaborators
Mayo Clinic
National Cancer Institute (NCI)
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

Responsible Party: Mayo Clinic Identifier: NCT00936728     History of Changes
Other Study ID Numbers: RC08C6
NCI-2009-01130 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
R01CA124614 ( U.S. NIH Grant/Contract )
RC08C6 ( Other Identifier: Mayo Clinic Cancer Center )
09-000862 ( Other Identifier: Mayo Clinic IRB )
First Posted: July 10, 2009    Key Record Dates
Last Update Posted: February 6, 2018
Last Verified: February 2018