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

White Wine for Appetite Loss: A Randomized, Controlled, Non-Blinded Trial

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

Study Overview

• Status: Completed
• Conditions: Unspecified Adult Solid Tumor, Protocol Specific
• Intervention / Treatment: Other: questionnaire administration; Dietary supplement: white wine; Other: therapeutic nutritional supplementation

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.

• Study Type: Interventional
• Enrollment (Anticipated): 140
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States
      • Mayo Clinic in Arizona
  • Florida
    • Jacksonville, Florida, United States
      • Mayo Clinic in Florida
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic
  • Pennsylvania
    • Danville, Pennsylvania, United States, 17822-2001
      • Geisinger Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A (white wine); Patients consume white wine twice daily for 3-4 weeks.	Other: questionnaire administration; Ancillary studies; Dietary supplement: white wine; Given orally
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: questionnaire administration; Ancillary studies; Other: therapeutic nutritional supplementation; Given orally

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Difference in the percentage of patients who report an improvement in their appetite over the intervention period	First 3 weeks

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Academic and Community Cancer Research United
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Tom R. Fitch, M.D., Mayo Clinic; Principal Investigator: Amber L. Isley, M.D., Mayo Clinic

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2009
• Primary Completion (Actual): March 2, 2017
• Study Completion (Actual): April 17, 2017

Study Registration Dates

• First Submitted: July 6, 2009
• First Submitted That Met QC Criteria: July 9, 2009
• First Posted (Estimate): July 10, 2009

Study Record Updates

• Last Update Posted (Actual): February 1, 2023
• Last Update Submitted That Met QC Criteria: January 31, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: RC08C6 (Other Identifier: Mayo Clinic Cancer Center); NCI-2009-01130 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA124614 (U.S. NIH Grant/Contract); 09-000862 (Other Identifier: Mayo Clinic IRB)