A Randomized, Controlled Pilot Study to Evaluate the Immediate Effect of Targeted Exercise Therapy on Cancer-Related Fatigue in Cancer Survivors: The FatiGO Study.

Abstract

Objectives: Cancer-related fatigue (CRF) is a clinically relevant side effect that impairs cancer survivors after treatment cessation. Exercise interventions have proven effective; however, specific exercise modalities remain untested. The purpose of this study was to evaluate the feasibility of daily fatigue screenings and to show the impact of various exercise interventions on CRF. Methods: The randomized controlled pilot study ran for 4 weeks with 3 training sessions per week, in 5 groups: endurance versus strength (moderate- and vigorous-intensity levels for each) compared to a non-active control group. The primary outcome was feasibility; more specifically, it was evaluated whether the documentation with the Numerical Rating Scale (NRS) on a daily basis and the Multidimensional Fatigue Inventory (MFI) on a weekly basis are usable assessments to generate information about CRF. Results: Over the course of the 4-week intervention, 8.3% of the participants (n = 3) dropped out. Thirty-three of the initial 36 participants completed the exercise sessions with an adherence of 95%. Measurements of daily fatigue were collected three times per day, 85% of which were completely filled out. In regard to weekly fatigue, all but one of the questionnaires were submitted (99.5%). Neither during the intervention nor during the tests did any serious adverse events occur within the FatiGO study; hence, the exercise intervention is considered to be feasible for participants. Conclusions: This pilot study showed the feasibility of close-meshed daily fatigue screening. Preliminary data indicate that cancer survivors are able to train in high-intensity ranges with tendencies toward decreased fatigue. Therefore, practicability of the study design is shown. Further results are expected within the prospective multicenter trial.