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The RESTORE Randomized Controlled Trial: Impact of a Multidisciplinary Rehabilitative Program on Cardiorespiratory Fitness in Esophagogastric cancer Survivorship

O’Neill, Linda M., MSc*; Guinan, Emer, PhD; Doyle, Suzanne L., PhD; Bennett, Annemarie E., PhD§; Murphy, Conor, MB, BCh||; Elliott, Jessie A., PhD, MRCS||; O'Sullivan, Jacintha, PhD; Reynolds, John V., MD, FRCS; Hussey, Juliette, PhD*

doi: 10.1097/SLA.0000000000002895
ESA-RANDOMIZED CONTROLLED TRIALS

Objective: The Rehabilitation Strategies in Esophagogastric cancer (RESTORE) randomized controlled trial evaluated the efficacy of a 12-week multidisciplinary program to increase the cardiorespiratory fitness and health-related quality of life (HRQOL) of esophagogastric cancer survivors.

Background: Patients following treatment for esophagogastric cancer are at risk of physical deconditioning, nutritional compromise, and sarcopenia. Accordingly, compelling rationale exists to target these impairments in recovery.

Methods: Disease-free patients treated for esophagogastric cancer were randomized to either usual care or the 12-week RESTORE program (exercise training, dietary counseling, and multidisciplinary education). The primary outcome was cardiopulmonary exercise testing (VO2peak). Secondary outcomes included body composition (bioimpedance analysis), and HRQOL (EORTC-QLQ-C30). Outcomes were assessed at baseline (T0), postintervention (T1), and at 3-month follow-up (T2).

Results: Twenty-two participants were randomized to the control group [mean (standard deviation) age 64.14 (10.46) yr, body mass index 25.67 (4.83) kg/m2, time postsurgery 33.68 (19.56) mo], and 21 to the intervention group [age 67.19(7.49) yr, body mass index 25.69(4.02) kg/m2, time postsurgery 23.52(15.23) mo]. Mean adherence to prescribed exercise sessions were 94(12)% (supervised) and 78(27)% (unsupervised). Correcting for baseline VO2peak, the intervention arm had significantly higher VO2peak at both T1, 22.20 (4.35) versus 21.41 (4.49) mL · min−1 · kg−1, P < 0.001, and T2, 21.75 (4.27) versus 20.74 (4.65) mL · min−1 · kg−1, P = 0.001, compared with the control group. Correcting for baseline values, no changes in body composition or HRQOL were observed.

Conclusions: The RESTORE program significantly improved cardiorespiratory fitness of disease-free patients after esophagogastric cancer surgery, without compromise to body composition. This randomized controlled trial provides proof of principle for rehabilitation programs in esophagogastric cancer.

Clinical Trial Registration Number: NCT03314311.

*Discipline of Physiotherapy, School of Medicine, Trinity College Dublin, Dublin, Ireland

School of Medicine, Trinity College Dublin, Dublin, Ireland

School of Biological Sciences, Dublin Institute of Technology, Dublin, Ireland

§Department of Clinical Medicine, Trinity College Dublin, Dublin, Ireland

||National Esophageal and Gastric Center, St. James's Hospital and Trinity College Dublin, Dublin, Ireland

Department of Surgery, Trinity Translational Medicine Institute, Trinity College Dublin and St. James's Hospital, Dublin, Ireland.

Reprints: John V. Reynolds, MD, FRCS, Department of Surgery, Trinity Centre for Health Sciences, St James's Hospital, Dublin 8, Ireland, D08 W9RT. E-mail: reynoldsjv@stjames.ie.

This study was funded by a Health Research Board Grant (HRA-POR-2014-535).

The authors report no conflicts of interest.

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