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

Mayo Clinic

Status: Completed

Conditions: Unspecified Adult Solid Tumor, Protocol Specific

Treatments: Other: questionnaire administration; Other: therapeutic nutritional supplementation; Dietary Supplement: white wine

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00936728

NCI-2009-01130 (Registry Identifier)

R01CA124614 (U.S. NIH Grant/Contract)

RC08C6 (Other Identifier)

09-000862 (Other Identifier)

Details and patient eligibility

About

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

Full 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.

Enrollment: 140 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Arm A (white wine)

Experimental group

Description:

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

Treatment:

Dietary Supplement: white wine

Other: questionnaire administration

Arm B (non-wine nutritional supplement)

Active Comparator group

Description:

Patients receive an oral non-wine nutritional supplement (e.g., Boost or Ensure) twice daily for 3-4 weeks.

Treatment:

Other: therapeutic nutritional supplementation

Other: questionnaire administration