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

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 NTR5045 Date of trial registration: January 19th, 2015Date and version study protocol: February 2017, version 1

Recent advancements in esophageal cancer treatment in Japan

“…The primary outcome is health‐related QOL. Because the design of the exercise program closely resembles daily practice, this study is expected to contribute both to evidence on the effects of exercise in EC patients and to potential implementation strategies . An examination of how we should invasively treat elderly EC patients was also reported by Vlacich et al.…”

Energy balance and gastrointestinal cancer: risk, interventions, outcomes and mechanisms

“…No differences in overall survival were reported 30 . Clinical trials exploring the effect of intentional weight loss or physical activity interventions in patients diagnosed with primary gastric and/or oesophageal tumours who underwent surgery with curative intent (for example, the Physical Exercise Following Esophageal Cancer Treatment (PERFECT) study; NTR5045) 41 are underway but have not yet been published.…”

Identifying outcomes reported in exercise interventions in oesophagogastric cancer survivors: a systematic review

“…The study characteristics of the six included studies are outlined in Table 1 . The included studies comprise three randomised control trials (RCTs) [ 5 , 6 , 24 ], two single arm feasibility studies [ 21 – 23 ], and one protocol for an RCT [ 25 ]. All included studies were published between 2017 and 2020.…”

“…Four of the studies included participants who had oesophageal cancer only [ 6 , 21 , 22 , 24 , 25 ], one study included participants who had gastric cancer only [ 23 ], and one study included participants who had either oesophageal, oesophageal junction, or gastric cancers [ 5 ]. Surgery was used as a treatment technique in all studies.…”