1. Fatigue, quality of life and physical fitness following an exercise intervention in multiple myeloma survivors (MASCOT): an exploratory randomised Phase 2 trial utilising a modified Zelen design
- Author
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Rebecca J. Beeken, Orla McCourt, Allan Hackshaw, Bruce Paton, Stephanie Philpott, Dimitrios A. Koutoukidis, Ali Rismani, Atul Mehta, Charalampia Kyriakou, Rakesh Popat, Joanne Land, Dunnya De-Silva, Xenofon Papanikolaou, Malgorzata Heinrich, Abigail Fisher, Kwee Yong, and Neil Rabin
- Subjects
Quality of life ,Cancer Research ,medicine.medical_specialty ,medicine.medical_treatment ,Physical fitness ,Myeloma ,Article ,03 medical and health sciences ,0302 clinical medicine ,medicine ,Humans ,Survivors ,030212 general & internal medicine ,Adverse effect ,Cardiovascular fitness ,Fatigue ,Multiple myeloma ,Rehabilitation ,business.industry ,Reproducibility of Results ,medicine.disease ,Exercise Therapy ,Oncology ,Outcomes research ,Physical Fitness ,030220 oncology & carcinogenesis ,Physical therapy ,Multiple Myeloma ,business ,Cohort study - Abstract
Background Exercise may improve fatigue in multiple myeloma survivors, but trial evidence is limited, and exercise may be perceived as risky in this older patient group with osteolytic bone destruction. Methods In this Phase 2 Zelen trial, multiple myeloma survivors who had completed treatment at least 6 weeks ago, or were on maintenance only, were enrolled in a cohort study and randomly assigned to usual care or a 6-month exercise programme of tailored aerobic and resistance training. Outcome assessors and usual care participants were masked. The primary outcome was the FACIT-F fatigue score with higher scores denoting less fatigue. Results During 2014–2016, 131 participants were randomised 3:1 to intervention (n = 89) or usual care (n = 42) to allow for patients declining allocation to the exercise arm. There was no difference between groups in fatigue at 3 months (between-group mean difference: 1.6 [95% CI: −1.1–4.3]) or 6 months (0.3 [95% CI: −2.6–3.1]). Muscle strength improved at 3 months (8.4 kg [95% CI: 0.5–16.3]) and 6 months (10.8 kg [95% CI: 1.2–20.5]). Using per-protocol analysis, cardiovascular fitness improved at 3 months (+1.2 ml/kg/min [95% CI: 0.3–3.7]). In participants with clinical fatigue (n = 17), there was a trend towards less fatigue with exercise over 6 months (6.3 [95% CI: −0.6–13.3]). There were no serious adverse events. Conclusions Exercise appeared safe and improved muscle strength and cardiovascular fitness, but benefits in fatigue appeared limited to participants with clinical fatigue at baseline. Future studies should focus on patients with clinical fatigue. Clinical trial registration The study was registered with ISRCTN (38480455) and is completed.
- Published
- 2020
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