Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study: design of a randomized controlled trial

Jonna K Van Vulpen,Ewout A Kouwenhoven,Richard Van Hillegersberg,Eric J Hazebroek,Carlo C G Schippers,Peter D Siersema,Anne M May,Donald L Van Der Peet,Petra H M Peeters,Grard A P Nieuwenhuijzen,Elles Steenhagen,Camiel Rosman,Richard P R Groenendijk

doi:10.1186/s12885-017-3542-8

Abstract

BackgroundFollowing esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. Beneficial effects of post-operative physical exercise have been reported in several cancer types, but so far comparable evidence in esophageal cancer patients is lacking. The aim of this study is to investigate effects of physical exercise on health-related quality of life in esophageal cancer patients following surgery.MethodsThe Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is a multicenter randomized controlled trial including 150 esophageal cancer patients after surgery with curative intent. Patients are randomly allocated to an exercise group or usual care group. The exercise group participates in a 12-week combined aerobic and resistance exercise program, supervised by a physiotherapist near the patient’s home-address. In addition, participants in the exercise group are requested to be physically active for at least 30 min per day, every day of the week. Participants allocated to the usual care group are asked to maintain their habitual physical activity pattern. The primary outcome is health-related quality of life (EORTC-QLQ-C30). Secondary outcomes include esophageal cancer specific quality of life, fatigue, anxiety and depression, sleep quality, work-related factors, cardiorespiratory fitness (VO2peak), muscle strength, physical activity, malnutrition risk, anthropometry, blood markers, recurrence of disease and survival. All questionnaire outcomes, diaries and accelerometers are assessed at baseline, post-intervention (12 weeks post-baseline) and 24 weeks post-baseline. Physical fitness, anthropometry and blood markers are assessed at baseline and post-intervention. In addition, adherence and safety are monitored throughout the exercise program.DiscussionThis randomized controlled trial investigates effects of physical exercise versus usual care in esophageal cancer patients after surgery. As the design of the exercise program closely resembles daily practice, this study can contribute both to evidence on effects of exercise in esophageal cancer patients, and to potential implementation strategies.Trial registrationTrial registration:Netherlands Trial Registry NTR5045Date of trial registration: January 19th, 2015Date and version study protocol: February 2017, version 1

Highlights

Following esophagectomy, esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term
In the 30–40% of patients who are eligible for a potential curative treatment, the combination of surgery with neoadjuvant chemoradiotherapy has provided a considerable survival benefit compared to surgery alone (Hazard Ratio: 0.78; 95% Confidence Interval (CI) 0.70 to 0.88) [3], leading to a 5-year survival of 47% in this particular group of patients [4]
The Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) study is designed as a multicenter, randomized controlled trial with two study arms: (1) a group offered a supervised exercise program in addition to usual care and (2) a control group receiving usual care without exercise intervention

Summary

Introduction

Esophageal cancer patients experience a clinically relevant deterioration of health-related quality of life, both on the short- and long-term. With the currently growing number of esophageal cancer survivors, the burden of disease- and treatment-related complaints and symptoms becomes more relevant. This emphasizes the need for interventions aimed at improving quality of life. The aim of this study is to investigate effects of physical exercise on healthrelated quality of life in esophageal cancer patients following surgery. With a growing number of esophageal cancer survivors, the burden of disease- and treatment-related problems increases, and interventions aimed at improving HRQoL are needed

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Methods

Conclusion