|- candidate number||21590|
|- NTR Number||NTR5045|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||19-jan-2015|
|- Secondary IDs||NL51091.041.14; 14-577 CCMO; METC|
|- Public Title||PERFECT Study|
|- Scientific Title||Physical ExeRcise Following Esophageal Cancer Treatment (PERFECT) Study: a randomized clinical trial |
|- ACRONYM||PERFECT Study|
|- hypothesis||We hypothesize that physical exercise following esophageal cancer surgery will improve health-related quality of life.|
|- Healt Condition(s) or Problem(s) studied||Esophageal cancer|
|- Inclusion criteria||1. Patients after EC resection with curative intent, with or without neoadjuvant chemoradiation;|
2. Patients >=18 years of age;
3. Patients with sufficient Dutch writing and reading skills;
4. Patients who exercise <= 150 min/week; 5. Karnofsky Performance status >=60;
6. Able to walk >=60 m.
|- Exclusion criteria||1. Presence of metastatic disease; |
2. Irradical resection;
3. Contra-indications for physical activity (R-PARQ).
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||28-jan-2015|
|- planned closingdate||1-jan-2018|
|- Target number of participants||150|
|- Interventions||1. Intervention group – patients in this group will participate in a 12-week supervised combined endurance and resistance training program; |
2. Control group – usual care.
|- Primary outcome||Health-related quality of life.|
|- Secondary outcome||Fatigue; Physical fitness (cardiorespiratory fitness, muscle strength); Functional wellbeing and symptoms; Esophagus-specific QoL; Anxiety and depression; Diet; Sleep quality; Physical activity; Body composition; Work ability; Cancer recurrence; Overall survival |
|- Timepoints||Baseline, 12 weeks and 24 weeks after inclusion.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES||Dr. A.M. May|
|- CONTACT for SCIENTIFIC QUERIES||Dr. A.M. May|
|- Sponsor/Initiator ||University Medical Center Utrecht (UMCU)|
(Source(s) of Monetary or Material Support)
|World Cancer Research Fund |
|- Brief summary||Rationale:|
Patients after esophageal cancer surgery are often fatigued and have a decreased health-related quality of life and physical functioning in the short- and long-term. Exercise training interventions have been shown to effectively improve health-related quality of life in patients with various types of cancer. So far, comparable evidence for patients with esophageal cancer is lacking.
- To investigate whether a 12-week exercise intervention increases HRQoL in patients after curatively intended EC surgery compared to a usual care control group.
- To investigate whether a 12-week exercise intervention improves fatigue, physical activity, physical fitness, functional wellbeing and symptoms, esophagus-specific QoL, anxiety and depression, diet, sleep quality, body composition and work ability.
- To explore whether disease recurrence is lower and overall survival is higher in the exercise group than in the control group.
Randomized controlled clinical study.
150 esophageal cancer patients who have undergone surgery with curative intent.
Participants in the intervention group will participate in a 12-week supervised combined endurance and resistance training program. Participants in the control group will receive usual care.
Outcomes will be assessed immediately after ending the intervention (12 weeks; short-term) and 24 weeks post-baseline (long-term).
|- Main changes (audit trail)|
|- RECORD||19-jan-2015 - 18-apr-2015|