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

NCT00936728 | Completed DMC

• 4 other identifiers: RC08C6NCI-2009-01130R01CA12461409-000862
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 4

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

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Outcome Measures

Primary Outcomes (1)

• Difference in the percentage of patients who report an improvement in their appetite over the intervention period

  First 3 weeks

Secondary Outcomes (4)

• 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

Study Arms (2)

Arm A (white wine)

EXPERIMENTAL

Patients consume white wine twice daily for 3-4 weeks.

Dietary Supplement: white wine; Other: questionnaire administration

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.

Other: therapeutic nutritional supplementation; Other: questionnaire administration

Interventions

therapeutic nutritional supplementation OTHER

Given orally

Arm B (non-wine nutritional supplement)

white wine DIETARY_SUPPLEMENT

Given orally

Arm A (white wine)

questionnaire administration OTHER

Ancillary studies

Arm A (white wine); Arm B (non-wine nutritional supplement)

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Academic and Community Cancer Research United: lead
• National Cancer Institute (NCI): collaborator

Study Sites (4)

Mayo Clinic in Arizona

Scottsdale, Arizona, United States

Location

Mayo Clinic in Florida

Jacksonville, Florida, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Geisinger Medical Center

Danville, Pennsylvania, 17822-2001, United States

Location

Study Officials

• 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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 6, 2009
• First Posted: July 10, 2009
• Study Start: July 1, 2009
• Primary Completion: March 2, 2017
• Study Completion: April 17, 2017
• Last Updated: February 1, 2023

Record last verified: 2023-01

Locations

US (4)