Muscadine Grape Extract to Improve Fatigue

Phase 0 Completed 64 enrolled Wake Forest University Health Sciences National Cancer Institute (NCI) · collab National Center for Advancing Translational Sciences (NCATS) · collab

RandomizedParallel-groupDouble-blindSupportive care

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.

Timeline

Start: 2021-04-20
Primary completion: 2024-08-26
Completion: 2024-08-26

Outcome

Missed primary endpoint

registry analysis (superiority test); Muscadine Grape Extract Arm vs Placebo Arm; Mean Difference (Final Values) -1.2 (90% CI -3.5 to 1.1) NCT04495751 ↗

Publications

Klepin HD, Tooze JA, Bitting RL, Davis B, Pleasant K, Melo AC, Cook K, Soto-Pantoja DR, Tallant EA, Gallagher PE. Study design and methods for the pilot study of muscadine grape extract supplement to improve fatigue among older adult cancer survivors (FOCUS) trial. J Geriatr Oncol. 2023 May;14(4):101478. doi: 10.1016/j.jgo.2023.101478. Epub 2023 Mar 27.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Muscadine grape extract	Unknown	—	Oral

Indications

No indication recorded.