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

Status:Active, not recruiting
Therapuetic Areas:Oncology
Age Range:21 - Any
Start Date:July 2009
End Date:September 2018

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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


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.

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

- 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
We found this trial at
100 North Academy Avenue
Danville, Pennsylvania 17822
Geisinger Medical Center Since 1915, Geisinger Medical Center has been known as the region’s resource...
Danville, PA
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4500 San Pablo Rd S
Jacksonville, Florida 32224
(904) 953-2000
Mayo Clinic Florida Thousands of people come to Mayo Clinic in Jacksonville, Fla., annually for...
Jacksonville, FL
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Rochester, Minnesota 55905
Rochester, MN
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13400 E. Shea Blvd.
Scottsdale, Arizona 85259
Mayo Clinic Arizona Mayo Clinic in Arizona provides medical care for thousands of people from...
Scottsdale, AZ
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