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Early Phase 1 N=64 Randomized Double-blind Supportive Care

Muscadine Grape Extract to Improve Fatigue

Fatigue

Enrolled (actual)
64
Serious AEs
1.6%
Results posted
Oct 2025
Primary outcome: Primary: Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire — -6.6; -5.4 score on a scale

Study Design & Population

Study type
Interventional
Phase
Early Phase 1
Interventions
Muscadine grape extract (Dietary_supplement); Placebo (Drug); Quality of Life Assessment (Other); Questionnaires (Other); Participant Feedback (Other)
Age
Older Adult · 65+ yrs
Sex
All
Sponsor
Wake Forest University Health Sciences
Primary completion
Aug 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Patient Reported Outcomes Measurement System (PROMIS) Fatigue 7a Questionnaire
-6.6; -5.4
SECONDARY
Pepper Assessment Tool for Disability (PAT-D) Questionnaire - Change From Baseline at 12 Weeks
1.4; 1.6
SECONDARY
Short Physical Performance Battery (SPPB)
9.8; 9.2
SECONDARY
Short Form Minnesota Leisure Time Activity Questionnaire (MLTA)
3218; 4192
SECONDARY
6-Minute Walk Test
369.8; 349.1
SECONDARY
Longitudinal Aging Study Amsterdam (LASA) Sedentary Behavior Questionnaire
13.2; 12.7
SECONDARY
Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health Short Form (SF) - Quality of Life
3.4; 3.2; 3.9; 3.7; 47.2; 46.3
SECONDARY
Adherence - Pill Count
569.1; 568.0
SECONDARY
Fried Frailty Index
0.9; 0.9

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 Criteria

  • 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) 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 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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04495751). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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