Efficacy of Treatment With Armodafinil for Cancer-Related Fatigue in Patients With High-grade Glioma: A Phase 3 Randomized Clinical Trial.

ABSTRACT:

Importance

Nearly 96% of patients with high-grade glioma (HGG) report moderate-to-severe fatigue. Armodafinil is a psychostimulant that might help cancer-related fatigue in patients with HGG.

Objective

To determine whether armodafinil reduces fatigue in patients with HGG and moderate-to-severe fatigue.

Design, setting, and participants

In this randomized multicenter, phase 3, double-blinded, placebo-controlled clinical trial, adults with HGG and moderate-to-severe fatigue who were clinically stable at least 4 weeks after completing radiation therapy were randomized to receive armodafinil daily (150 mg or 250 mg) or placebo over 8 weeks. A score of at least 6 out of 10 on severity scale for the brief fatigue inventory scale, with 10 being the worst, was required to sug

SUBMITTER: Porter AB 

PROVIDER: S-EPMC8662535 | biostudies-literature | 2022 Feb

REPOSITORIES: biostudies-literature