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PERFECT Study


- candidate number21590
- NTR NumberNTR5045
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR19-jan-2015
- Secondary IDsNL51091.041.14; 14-577 CCMO; METC
- Public TitlePERFECT Study
- Scientific TitlePhysical ExeRcise Following Esophageal Cancer Treatment (PERFECT) Study: a randomized clinical trial
- ACRONYMPERFECT Study
- hypothesisWe hypothesize that physical exercise following esophageal cancer surgery will improve health-related quality of life.
- Healt Condition(s) or Problem(s) studiedEsophageal cancer
- Inclusion criteria1. 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 criteria1. Presence of metastatic disease;
2. Irradical resection;
3. Contra-indications for physical activity (R-PARQ).
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 28-jan-2015
- planned closingdate1-jan-2018
- Target number of participants150
- Interventions1. 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 outcomeHealth-related quality of life.
- Secondary outcomeFatigue; 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
- TimepointsBaseline, 12 weeks and 24 weeks after inclusion.
- Trial web siteN/A
- statusplanned
- CONTACT FOR PUBLIC QUERIESDr. A.M. May
- CONTACT for SCIENTIFIC QUERIESDr. A.M. May
- Sponsor/Initiator University Medical Center Utrecht (UMCU)
- Funding
(Source(s) of Monetary or Material Support)
World Cancer Research Fund
- PublicationsN/A
- Brief summaryRationale:
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.

Primary objective:
- To investigate whether a 12-week exercise intervention increases HRQoL in patients after curatively intended EC surgery compared to a usual care control group.

Secondary Objectives:
- 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.

Study design:
Randomized controlled clinical study.

Study population:
150 esophageal cancer patients who have undergone surgery with curative intent.

Intervention:
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.

Outcome:
Outcomes will be assessed immediately after ending the intervention (12 weeks; short-term) and 24 weeks post-baseline (long-term).
- Main changes (audit trail)
- RECORD19-jan-2015 - 18-apr-2015


  • Indien u gegevens wilt toevoegen of veranderen, kunt u een mail sturen naar nederlands@trialregister.nl