Study design and methods for the pilot study of muscadine grape extract supplement to improve fatigue among older adult cancer survivors (FOCUS) trial.

ABSTRACT:

Introduction

Fatigue is a prevalent symptom among both cancer survivors and older adults. Negative consequences of fatigue include increased sedentary behavior, decreased physical activity and function, and lower quality of life. Few pharmacologic interventions improve fatigue. Our preclinical and clinical data show promising effects of a muscadine grape extract supplement (MGES) on oxidative stress, mitochondrial bioenergetics, the microbiome, and the symptom of fatigue. This pilot study seeks to translate these observations to cancer survivorship by testing the preliminary effect of MGE supplementation on older adult cancer survivors with self-reported fatigue.

Materials and methods

We designed a double-blinded placebo-controlled pilot study to evaluate preliminary efficac

SUBMITTER: Klepin HD 

PROVIDER: S-EPMC10164712 | biostudies-literature | 2023 May

REPOSITORIES: biostudies-literature