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Dietary Supplement
Muscadine Grape Extract for Fatigue
Phase < 1
Recruiting
Led By Heidi Klepin, MD, MS
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eligible hematologic malignancies include lymphoma any subtype any stage in remission, multiple myeloma in remission, leukemia any subtype in remission.
Age 65 years and older
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial is testing if a grape supplement can help reduce fatigue in cancer patients over 70.
Who is the study for?
This trial is for people aged 70 or older who have been treated for certain types of cancer, are in remission, and suffer from fatigue. They must be able to walk (with aids like canes if needed), have normal organ function, not require oxygen for lung disease, and not be on treatments like Coumadin or Warfarin.Check my eligibility
What is being tested?
Researchers are testing whether muscadine grape extract can help improve fatigue in elderly individuals with a history of treated cancer. Participants will either receive the grape extract or a placebo and provide feedback through questionnaires assessing their quality of life.See study design
What are the potential side effects?
Potential side effects aren't specified but could include allergic reactions to muscadine grapes for those sensitive to them. As it's a natural extract being tested against a placebo, other side effects may be minimal.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My blood cancer (like lymphoma, leukemia, or multiple myeloma) is currently in remission.
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I am 65 years old or older.
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I have felt fatigued to a significant degree in the past week.
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I can walk by myself, but I may use a cane or walker.
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My kidneys are functioning well enough (creatinine clearance over 30 mL/min).
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire
Secondary outcome measures
6-Minute Walk Test
Adherence - Pill Count
Fried Frailty Index
+5 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Muscadine Grape Extract ArmExperimental Treatment4 Interventions
Muscadine grape extract pill (12 week supply)
Group II: Placebo ArmPlacebo Group4 Interventions
Placebo provided (12 week supply)
Find a Location
Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,242 Previous Clinical Trials
1,004,203 Total Patients Enrolled
15 Trials studying Fatigue
2,224 Patients Enrolled for Fatigue
Heidi Klepin, MD, MSPrincipal InvestigatorWake Forest University Health Sciences
1 Previous Clinical Trials
25 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am currently receiving treatment for cancer, including hormone therapy or immunotherapy.I can walk by myself, but I may use a cane or walker.I cannot swallow pills.I can understand and am willing to sign the consent form.My kidneys are functioning well enough (creatinine clearance over 30 mL/min).I experience nausea or diarrhea at least once a week.I had cancer, not skin cancer, over a year ago but am now cancer-free.I do not have any severe illnesses or social situations that would stop me from following the study's requirements.I have felt fatigued to a significant degree in the past week.My blood cancer (like lymphoma, leukemia, or multiple myeloma) is currently in remission.I am on dialysis for end-stage kidney disease.My blood tests for organ and bone marrow function are normal.I have been diagnosed with hypothyroidism but haven't started treatment.I am not taking Coumadin or Warfarin but may be on other blood thinners.I have symptoms of heart failure.You are allergic to muscadine grapes or anything made from them.I have had cancer treatments like surgery, radiation, or chemotherapy.I have been diagnosed with dementia.I finished all cancer treatments more than a year ago.I am 65 years old or older.I need oxygen therapy for my lung condition.I am undergoing hormone therapy for my cancer.My cancer is in stages 1-3 and is not just on the surface or in situ.
Research Study Groups:
This trial has the following groups:- Group 1: Placebo Arm
- Group 2: Muscadine Grape Extract Arm
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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