NCT04495751

Muscadine Grape Extract to Improve Fatigue

FOCUS - Pilot Study of Muscadine Grape Extract to Improve Fatigue Among Older Adult Cancer Survivors

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 64 (actual)
• Sponsor: Wake Forest University Health Sciences · Academic / Other
• Sex: All
• Age: 65 Years
• Healthy volunteers: Not accepted

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 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.

Conditions

• Fatigue

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Muscadine grape extract	Four pills twice daily
DRUG	Placebo	Four pills twice daily.
OTHER	Quality of Life Assessment	Ancillary studies
OTHER	Questionnaires	Ancillary studies
OTHER	Participant Feedback	Ancillary studies

Timeline

• Start date: 2021-04-20
• Primary completion: 2024-08-26
• Completion: 2024-08-26
• First posted: 2020-08-03
• Last updated: 2025-10-16
• Results posted: 2025-10-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study