Trial Information
Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care
Outcome Measure:
Body composition
Outcome Description:
Lean body mass and fat mass assessed by DEXA scanning
Outcome Time Frame:
Baseline, 3 months and 6 months
Safety Issue:
No
Principal Investigator
Jens Overgaard, Prof., MD
Investigator Role:
Principal Investigator
Investigator Affiliation:
Danish Head and Neck Cancer Group
Authority:
Denmark: Danish Dataprotection Agency
Study ID:
DAHANCA 25B
NCT ID:
NCT01509430
Start Date:
October 2011
Completion Date:
April 2013
Related Keywords:
- Head and Neck Cancer
- Carcinoma, Squamous Cell
- Head and Neck Neoplasms