DAHANCA 25B: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC

Study Overview
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Brief Summary
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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.

Official Title
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Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial

Conditions
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Head and Neck Cancer

Intervention / Treatment
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* Other: Progressive Resistance Exercise Training
* Other: Progressive Resistance Exercise Training


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Early training patient<br>12 weeks of Progressive Resistance Training followed by 12 weeks of a self chosen level of physical activity | Other: Progressive Resistance Exercise Training<br>* 12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training<br>|
| Experimental: Late training patients<br>12 weeks of a self chosen level of physical activity followed by 12 weeks of progressive resistance training | Other: Progressive Resistance Exercise Training<br>* 12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body composition | Lean body mass and fat mass assessed by DEXA scanning | Baseline, 3 months and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximal muscle strength | Isometric and isokinetic muscle dynamometry | Baseline, 3 months and 6 months | 
| Maximal gait speed | 10 m walk time | Baseline, 3 months and 6 months | 
| Patient reported outcomes | Questionaires on Quality of Life, Fatigue and Mood | Baseline, 3 months and 6 months | 
| Blood sampling | Investigation of changes in serum level of markers related to weight loss, inflammation and muscle hypertrophy | Baseline, 3 months and 6 months | 
| 30 s arm curl capacity |  | Baseline, 3 months, 6 months | 
| Stair climbing capacity |  | Baseline, 3 months, 6 months | 
| Jumping capacity | Counter Movement Jumps | Baseline, 3 months, 6 months | 
| Chair rise capacity | 30 s chair rise | Baseline, 3 months, 6 months |