Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma
This study has been completed.
Sponsor:
Danish Head and Neck Cancer Group
Information provided by (Responsible Party):
Jens Overgaard, Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier:
NCT01509430
First received: January 3, 2012
Last updated: April 15, 2013
Last verified: April 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 3, 2012 | ||||
| Last Updated Date | April 15, 2013 | ||||
| Start Date ICMJE | October 2011 | ||||
| Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Body composition [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ] Lean body mass and fat mass assessed by DEXA scanning |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01509430 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE |
|
||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With Head and Neck Squamous Cell Carcinoma | ||||
| Official Title ICMJE | Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial | ||||
| Brief Summary | Head and neck cancer patients often experience a critical weight loss of around 10% following radiation therapy. Of this up to 70% is muscle mass and is an independent predictor of mortality, lowers muscle strength and functional performance. The purpose of this study is in a randomized controlled trial to investigate the effects of progressive resistance training (PRET) on changes in muscle mass, muscle strength and functional performance in head and neck cancer survivors. The investigators hypothesize that PRET has a positive effect on all primary endpoints and increases muscle mass, muscle strength and functional performance. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Not Provided | ||||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
||||
| Condition ICMJE | Head and Neck Cancer | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 41 | ||||
| Completion Date | April 2013 | ||||
| Primary Completion Date | April 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Denmark | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01509430 | ||||
| Other Study ID Numbers ICMJE | DAHANCA 25B | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Jens Overgaard, Danish Head and Neck Cancer Group | ||||
| Study Sponsor ICMJE | Danish Head and Neck Cancer Group | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Danish Head and Neck Cancer Group | ||||
| Verification Date | April 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||