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
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Head and Neck Cancer |
Other: Progressive Resistance Exercise Training |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Supportive Care |
| Official Title: | Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial |
Resource links provided by NLM:
Further study details as provided by Danish Head and Neck Cancer Group:
Primary Outcome Measures:
- 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
Secondary Outcome Measures:
- Maximal muscle strength [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]Isometric and isokinetic muscle dynamometry
- Maximal gait speed [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]10 m walk time
- Patient reported outcomes [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]Questionaires on Quality of Life, Fatigue and Mood
- Blood sampling [ Time Frame: Baseline, 3 months and 6 months ] [ Designated as safety issue: No ]Investigation of changes in serum level of markers related to weigth loss, inflammation and muscle hypertrophy
- 30 s arm curl capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- Stair climbing capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]
- Jumping capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]Counter Movement Jumps
- Chair rise capacity [ Time Frame: Baseline, 3 months, 6 months ] [ Designated as safety issue: No ]30 s chair rise
| Enrollment: | 41 |
| Study Start Date: | October 2011 |
| Study Completion Date: | April 2013 |
| Primary Completion Date: | April 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Early training patient
12 weeks of Progressive Resistance Training followed by 12 weeks of a self chosen level of physical activity
|
Other: Progressive Resistance Exercise Training
12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training
|
|
Experimental: Late training patients
12 weeks of a self chosen level of physical activity followed by 12 weeks of progressive resistance training
|
Other: Progressive Resistance Exercise Training
12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Histologically diagnosed with squamous cell carcinomas of the larynx (no glottis stage I+II), pharynx, oral cavity or in lymph nodes from an unknown primary tumour (stage I-IV and tumour node metastasis (TNM) classification, UICC, Geneva, 1987)
- Terminated curative radiotherapy treatment with/without chemotherapy;
- No metastases
- Complete tumour remission
- No current or previous malignancies that could prevent participation and training
- No excessive alcohol intake (men > 21 and women > 14 units/wk)
- No recent systematic resistance training or creatine ingestion (within 2 months)
- If woman, not pregnant
- WHO performance status of 0-1
- No psychological, social or geographical conditions that could disturb participation
- Written consent
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01509430
Locations
| Denmark | |
| Dept. of Experimental Clinical Oncology | |
| Aarhus C, Denmark, 8000 | |
Sponsors and Collaborators
Danish Head and Neck Cancer Group
Investigators
| Principal Investigator: | Jens Overgaard, Prof., MD | Danish Head and Neck Cancer Group |
More Information
Additional Information:
No publications provided
| Responsible Party: | Jens Overgaard, Professor, MD, Danish Head and Neck Cancer Group |
| ClinicalTrials.gov Identifier: | NCT01509430 History of Changes |
| Other Study ID Numbers: | DAHANCA 25B |
| Study First Received: | January 3, 2012 |
| Last Updated: | April 15, 2013 |
| Health Authority: | Denmark: Danish Dataprotection Agency |
Additional relevant MeSH terms:
|
Carcinoma, Squamous Cell Head and Neck Neoplasms Carcinoma Neoplasms, Glandular and Epithelial |
Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell Neoplasms by Site |
ClinicalTrials.gov processed this record on May 19, 2013