Unspecified Adult Solid Tumor, Protocol SpecificNCT00936728
White Wine or Nutritional Supplement in Improving Appetite in Patients With Cancer
A study testing therapeutic nutritional supplementation, white wine and questionnaire administration in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Academic and Community Cancer Research United at 4 sites in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Unspecified Adult Solid Tumor, Protocol Specific
- What is being tested?
- therapeutic nutritional supplementation, white wine and questionnaire administration
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2009to 17 Apr 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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
Who cannot join
- 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 locations and contacts
4 sites in 1 country.
United States4 sites
Geisinger Medical Center
Danville, Pennsylvania, 17822-2001
Mayo Clinic in Florida
Jacksonville, Florida
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic in Arizona
Scottsdale, Arizona
About this study
Official title: 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
Read the detailed description
OBJECTIVES:
- 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.
- Being tested
- therapeutic nutritional supplementation, white wine, questionnaire administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic nutritional supplementationOther
Given orally
white wineDietary supplement
Given orally
questionnaire administrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm A (white wine) | Experimental | Patients consume white wine twice daily for 3-4 weeks. Receives: 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. Receives: Other: therapeutic nutritional supplementation; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in the percentage of patients who report an improvement in their appetite over the intervention period
Measured: 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
Measured: At one month
Overall survival
Measured: Every 6 months for 2 years
Incidence of study intervention-related toxicity
Measured: 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
Measured: Prior to study intervention and then weekly
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2009 (estimated)
- Study startJul 2009
- Primary completion2 Mar 2017
- Study completion17 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Unspecified Adult Solid Tumor, Protocol SpecificStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academic and Community Cancer Research United
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Aminah Jatoi, M.D., Study chair, Mayo ClinicTom R. Fitch, M.D., Principal investigator, Mayo ClinicAmber L. Isley, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00936728
- Sponsor's protocol ID
- RC08C6
- Other IDs
- NCI-2009-01130, R01CA124614, RC08C6, 09-000862
- Status last verified
- Jan 2023
- First submitted
- 6 Jul 2009
- Last updated
- 1 Feb 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Wine for Appetite Loss: A Randomized, Controlled, Non-Blinded Trial
- ClinicalTrials.gov ID
- NCT00936728
- Acronym / sponsor ID
- RC08C6
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Academic and Community Cancer Research UnitedUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2009 (actual)
- Primary completion
- 2 Mar 2017 (actual)
- Study completion
- 17 Apr 2017 (actual)
- First posted
- 10 Jul 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
OBJECTIVES:
- 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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm A (white wine) | Experimental | Dietary Supplement: white wine, Other: questionnaire administrationPatients consume white wine twice daily for 3-4 weeks. |
| Arm B (non-wine nutritional supplement) | Active comparator | Other: therapeutic nutritional supplementation, Other: questionnaire administrationPatients receive an oral non-wine nutritional supplement (e.g., Boost or Ensure) twice daily for 3-4 weeks. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic nutritional supplementationGiven orally | Other | Arm B (non-wine nutritional supplement) |
| white wineGiven orally | Dietary supplement | Arm A (white wine) |
| questionnaire administrationAncillary studies | Other | Arm A (white wine), Arm B (non-wine nutritional supplement) |
Primary outcome
Difference in the percentage of patients who report an improvement in their appetite over the intervention period
Time frame: First 3 weeks
4 secondary outcomes
Differences in the percentage of patients who manifest weight stability, defined as weight gain of at least 5% of baseline
Time frame: At one month
Overall survival
Time frame: Every 6 months for 2 years
Incidence of study intervention-related toxicity
Time frame: 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
Time frame: Prior to study intervention and then weekly
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aminah Jatoi, M.D. study chair
Mayo Clinic
Tom R. Fitch, M.D. principal investigator
Mayo Clinic
Amber L. Isley, M.D. principal investigator
Mayo Clinic
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic nutritional supplementation, white wine and questionnaire administration in people with Unspecified Adult Solid Tumor, Protocol Specific, run by Academic and Community Cancer Research United at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in the percentage of patients who report an improvement in their appetite over the intervention period (time frame: First 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2023.