Early Phase 1
N=64
Muscadine Grape Extract to Improve Fatigue
Fatigue
Bottom Line
View on ClinicalTrials.gov: NCT04495751 ↗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
| Outcome | Result | p-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
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.