White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer - Full Text View

Purpose

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	Intervention
Unspecified Adult Solid Tumor, Protocol Specific	Other: therapeutic nutritional supplementation Dietary Supplement: white wine Other: questionnaire administration

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Official Title:	White Wine for Appetite Loss: A Randomized, Controlled, Non-Blinded Trial

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements

U.S. FDA Resources

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:

Difference in the percentage of patients who report an improvement in their appetite over the intervention period [ Time Frame: First 3 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

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 ] [ Designated as safety issue: No ]
Overall survival [ Time Frame: Every 6 months for 2 years ] [ Designated as safety issue: No ]
Incidence of study intervention-related toxicity [ Time Frame: Prior to registration and at week 3-4 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]

Estimated Enrollment:	140
Study Start Date:	July 2009
Estimated Primary Completion Date:	July 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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

Ages Eligible for Study:	21 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00936728

Locations

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

Sponsors and Collaborators

Mayo Clinic

National Cancer Institute (NCI)

Investigators

Study Chair:	Aminah Jatoi, M.D.	Mayo Clinic
Principal Investigator:	Tom R. Fitch, M.D.	Mayo Clinic in Arizona
Principal Investigator:	Amber L. Isley, M.D.	Mayo Clinic in Florida

More Information

No publications provided

Responsible Party:	Aminah Jatoi, M.D., Mayo Clinic Cancer Center
ClinicalTrials.gov Identifier:	NCT00936728 History of Changes
Other Study ID Numbers:	RC08C6, NCI-2009-01130, R01CA124614, RC08C6, 09-000862
Study First Received:	July 6, 2009
Last Updated:	May 14, 2012
Health Authority:	United States: Federal Government

ClinicalTrials.gov processed this record on May 16, 2013