Muscadine Grape Extract to Improve Fatigue

Last updated: April 29, 2025
Sponsor: Wake Forest University Health Sciences
Overall Status: Completed

Phase

1

Condition

Pain (Pediatric)

Treatment

Quality of Life Assessment

Placebo

Participant Feedback

Clinical Study ID

NCT04495751
IRB00067614
UL1TR001420
WFBCCC 98320
P30CA012197
  • Ages > 65
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Self-reported history of cancer diagnosed > 12 months prior to enrollment excludingnon-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. (superficialdisease and in situ disease only is excluded)

  • Eligible hematologic malignancies include lymphoma any subtype any stage inremission, 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 orvery much" to the screening question "During the past seven days, did you feelfatigued: Not at all, a little bit, somewhat, quite a bit, very much?"

  • Ability to walk without requiring assistance from another individual (use of cane orwalker 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 consentdocument (either directly or via a legally authorized representative).

Exclusion

Exclusion Criteria:

  • 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 activeinfection, unstable angina pectoris, cardiac arrhythmia, or psychiatricillness/social situations that would limit compliance with study requirements.

  • Known untreated hypothyroidism

  • Allergy to muscadine grapes or muscadine grape preparations

Study Design

Total Participants: 64
Treatment Group(s): 5
Primary Treatment: Quality of Life Assessment
Phase: 1
Study Start date:
April 20, 2021
Estimated Completion Date:
August 26, 2024

Study 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 whether administration of muscadine grape extract supplementation (4 tablets twice daily) causes changes in physical function (Pepper Assessment Tool for Disability [PAT-D], Short Physical Performance Battery), physical fitness (6-minute walk), physical activity (Minnesota Leisure Questionnaire), sedentary behavior (Sedentary Behavior Questionnaire) from baseline to 12 weeks compared to placebo.

  • To compare changes in health related quality of life (PROMIS Global Health) at 12 weeks in participants randomized to muscadine grape extract group vs. placebo.

  • To compare changes in the Fried frailty index at 12 weeks in participants randomized to muscadine grape extract vs. placebo.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive muscadine grape extract orally (PO) twice daily (BID) for 12 weeks in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive placebo PO BID for 12 weeks in the absence of disease progression or unacceptable toxicity.

After completion of study, patients are followed up for 30 days after the last dose of the study drug.

Connect with a study center

  • Wake Forest Baptist Comprehensive Cancer Center

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

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