Respiratory Cancer Clinical Trial
— REINFORCEOfficial title:
Resistance Training in Radically Treated Respiratory Cancer Patients: a Prospective Randomized Multicenter Study
| Verified date | December 2014 |
| Source | University Hospital, Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Belgium: Institutional Review Board |
| Study type | Interventional |
The first part of the study is an observational part. In eligible patients with early stage respiratory cancer, the primary and secondary endpoints will be evaluated before and after their scheduled radical cancer therapy. The measured variables, include a blood sample, pulmonary function tests, level of dyspnea, exercise tests, measurement of body composition, respiratory and peripheral muscle force, health related quality of life and psychological status. Only registered participants having completed a radical treatment and having either less than 70% of the predicted normal value of the quadriceps force (QF) or a decrease of more than 10% predicted value of the QF between pre-and post radical treatment, will be allowed to participate to the second part of the study. These patients will then be randomized in three groups. Group A, the control group, will have the usual care and follow up according to clinical symptoms. Group B will be offered a conventional resistance training program (CRT), and group C, will be offered a whole body vibration resistance training (WBV) on the FITVIBE-platform. All previous variables will be measured after 6 and 12 weeks of training.
| Status | Completed |
| Enrollment | 113 |
| Est. completion date | July 2012 |
| Est. primary completion date | June 2012 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 80 Years |
| Eligibility |
Inclusion Criteria: - Patients with non-small cell or small cell lung cancer or mesothelioma candidate for radical treatment - either by surgical resection with or without perioperative chemotherapy - or by thoracic radiotherapy with or without chemotherapy - Between 18 and 80 years of age - Written informed consent Supplementary criteria for PART II: - Treatment for their cancer considered radical - either by surgical resection with or without perioperative chemotherapy - or by thoracic radiotherapy with or without chemotherapy - having less than 70% of the predicted normal value of the Quadriceps Force (QF) or a decrease of more than 10% predicted value of the QF between the baseline and post-radical therapy measurement of QF - Post treatment assessment maximum 14 days after radical treatment or between 6th and 8th week after radical treatment if the latter consists only of surgical resection Exclusion Criteria: Patients presenting with one or more of the following will be excluded: - Severe anemia (Hb below 8 g/dl) - Fever (> 38°C) - Cachexia (loss of more than 35% of premorbid weight) - Severe cardiac, neurological and orthopedic co-morbidity interfering with exercise training. - A pacemaker, hip, knee of shoulder prosthesis or recently introduced spirals, metal pens, bolts or plates - Uncontrolled diabetes, epilepsy or migraine - Uncontrolled vertebral diseases (osteoporotic or metastatic fractures, acute hernia, discopathy, spondylitis) - Open wounds |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
| Country | Name | City | State |
|---|---|---|---|
| Belgium | AZ St. Jan | Brugge | |
| Belgium | CHU Saint Pierre | Brussel | |
| Belgium | University Hospital Ghent | Ghent | |
| Belgium | CHU Sart Tilman | Liège |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Ghent | Agentschap voor Innovatie door Wetenschap en Technologie |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The change of 6MWD observed between pre-and post radical treatment | 12 weeks | No | |
| Primary | between post radical treatment and after a 12 week resistance training | 12 weeks | No | |
| Secondary | The changes of the following variables: Muscle strength | 12 weeks | No | |
| Secondary | Muscle mass | 12 weeks | No | |
| Secondary | Body composition | 12 weeks | No | |
| Secondary | Maximal exercise capacity | 12 weeks | No | |
| Secondary | Muscle force | 12 weeks | No | |
| Secondary | Quality of life | 12 weeks | No | |
| Secondary | Anxiety and depression scores | 12 weeks | No | |
| Secondary | Dyspnea scores | 12 weeks | No | |
| Secondary | 6MWD | 12 weeks | No |