No registrations found.
ID
Source
Brief title
Health condition
esophageal cancer; oesofaguscarcinoom; slokdarmkanker
Sponsors and support
Intervention
Outcome measures
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
Background 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.
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).
Study objective
We hypothesize that physical exercise following esophageal cancer surgery will improve health-related quality of life.
Study design
Baseline, 12 weeks and 24 weeks after inclusion.
Intervention
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.
A.M. May
P.O. Box 85500
Utrecht 3508 GA
The Netherlands
+31 (0)88 75 511 32
a.m.may@umcutrecht.nl
A.M. May
P.O. Box 85500
Utrecht 3508 GA
The Netherlands
+31 (0)88 75 511 32
a.m.may@umcutrecht.nl
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).
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
NTR-new | NL4942 |
NTR-old | NTR5045 |
CCMO | NL51091.041.14 |
OMON | NL-OMON47661 |