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

Sponsor
Academic and Community Cancer Research United (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT00936728
Collaborator
National Cancer Institute (NCI) (NIH)
140
4
2
158
35
0.2

Study Details

Study Description

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
  • Other: therapeutic nutritional supplementation
  • Dietary Supplement: white wine
  • Other: questionnaire administration
N/A

Detailed Description

OBJECTIVES:
  1. To compare white wine (Arm A) to non-wine nutritional supplement (Arm B) for the treatment of cancer-associated anorexia.

  2. 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 Design

Study Type:
Interventional
Anticipated 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 :
Jul 1, 2009
Anticipated Primary Completion Date :
Sep 1, 2022
Anticipated Study Completion Date :
Sep 1, 2022

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Difference in the percentage of patients who report an improvement in their appetite over the intervention period [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 [At one month]

  2. Overall survival [Every 6 months for 2 years]

  3. Incidence of study intervention-related toxicity [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 [Prior to study intervention and then weekly]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Mayo Clinic in Arizona Scottsdale Arizona United States
2 Mayo Clinic in Florida Jacksonville Florida United States
3 Mayo Clinic Rochester Minnesota United States 55905
4 Geisinger Medical Center Danville Pennsylvania United States 17822-2001

Sponsors and Collaborators

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

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Academic and Community Cancer Research United
ClinicalTrials.gov Identifier:
NCT00936728
Other Study ID Numbers:
  • RC08C6
  • NCI-2009-01130
  • R01CA124614
  • RC08C6
  • 09-000862
First Posted:
Jul 10, 2009
Last Update Posted:
Jul 20, 2021
Last Verified:
Jul 1, 2021

Study Results

No Results Posted as of Jul 20, 2021