Muscadine Grape Extract to Improve Fatigue

Completed · Early Phase 1 · Has a placebo group

Conditions studied: Fatigue

In brief

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.

Key facts

Study ID

NCT04495751

Run by

Wake Forest University Health Sciences

People needed

64

Starts

2021-04-20

Expected to finish

2024-08-26

Last updated by the study team

2025-10-16

Who can join

Age: 65 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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).

You may not qualify if…

• 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

Where it is running

• Wake Forest Baptist Comprehensive Cancer Center — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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