Status:
COMPLETED
Muscadine Grape Extract to Improve Fatigue
Lead Sponsor:
Wake Forest University Health Sciences
Collaborating Sponsors:
National Center for Advancing Translational Sciences (NCATS)
National Cancer Institute (NCI)
Conditions:
Fatigue
Eligibility:
All Genders
65+ years
Phase:
EARLY_PHASE1
Brief Summary
The purpose of this research is to see if muscadine grape extract improves fatigue in people age 70 and above who have a history of treated cancer and report the symptom of fatigue.
Detailed Description
Primary Objective: To evaluate whether administration of MGE supplementation decreases PROMIS Fatigue score from baseline to 12 weeks compared to placebo. Secondary Objective(s) * To evaluate whethe...
Eligibility Criteria
Inclusion
- Self-reported history of cancer diagnosed \> 12 months prior to enrollment excluding non-melanoma skin cancer with no evidence of disease at enrollment.
- Eligible solid tumor cancer types include Stage 1-3 breast, lung, head and neck, colorectal, anal, prostate, melanoma, bladder/ureteral, esophageal, gastric, pancreatic, kidney, liver/biliary, uterine, cervical, ovarian, sarcoma. (superficial disease and in situ disease only is excluded)
- Eligible hematologic malignancies include lymphoma any subtype any stage in remission, multiple myeloma in remission, leukemia any subtype in remission.
- Eligible prior cancer treatment modalities include surgery, radiation, chemotherapy, hormonal therapies, immunotherapy, biologic therapies.
- All anti-cancer therapy completed \> 12 months prior to enrollment
- Age 65 years and older
- Presence of self-reported fatigue defined by a response of "somewhat, quite a bit or very much" to the screening question "During the past seven days, did you feel fatigued: Not at all, a little bit, somewhat, quite a bit, very much?"
- Ability to walk without requiring assistance from another individual (use of cane or walker acceptable)
- Normal organ and marrow function as defined below:
- leukocytes \>3,000/mcL
- absolute neutrophil count \>1,500/mcL
- platelets \>100,000/mcL
- total bilirubin within normal institutional limits
- AST(SGOT)/ALT(SGPT) \<2.5 X institutional upper limit of normal
- creatinine clearance \>30 mL/min
- Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
Exclusion
- Active malignancy or on-going cancer treatment including oral anti-estrogen therapy, immunotherapy, biologic therapy.
- Men receiving androgen deprivation therapy
- Use of Coumadin or Warfarin (other blood thinners are acceptable)
- Symptomatic congestive heart failure
- Lung disease requiring oxygen
- End stage renal disease requiring dialysis
- Inability to swallow capsules
- Chronic nausea or diarrhea defined by a frequency of ≥ once per week
- Hemoglobin \<10 g/dl
- Diagnosis of dementia
- Uncontrolled intercurrent illness including, but not limited to ongoing or active infection, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements.
- Known untreated hypothyroidism
- Allergy to muscadine grapes or muscadine grape preparations
Key Trial Info
Start Date :
April 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 26 2024
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT04495751
Start Date
April 20 2021
End Date
August 26 2024
Last Update
October 16 2025
Active Locations (1)
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1
Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States, 27157