Clinical trial · Interventional
White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer
White Wine for Appetite Loss: A Randomized, Controlled, Non-Blinded Trial
NCT00936728CI-TRIAL-00063609completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| questionnaire administration | Other | — | UNRESOLVED |
| therapeutic nutritional supplementation | Other | — | UNRESOLVED |
| white wine | Dietary Supplement | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Arm A (white wine)
- description
- Patients consume white wine twice daily for 3-4 weeks.
- interventionNames
- Dietary Supplement: white wine
- Other: questionnaire administration
- type
- ACTIVE_COMPARATOR
- label
- Arm B (non-wine nutritional supplement)
- description
- Patients receive an oral non-wine nutritional supplement (e.g., Boost or Ensure) twice daily for 3-4 weeks.
- interventionNames
- Other: therapeutic nutritional supplementation
- Other: questionnaire administration
Primary outcomes (1)
- measure
- Difference in the percentage of patients who report an improvement in their appetite over the intervention period
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.