DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to investigate whether resistance training in combination with dietary supplementation is tolerable among head and neck cancer patients and to evaluate the possible effect on muscle mass, strength and functional capacity.

Detailed Description
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Head and neck cancer patients experience a significant loss of muscle mass following radiotherapy treatment due to cachexia and dysphagia. This negatively affects muscle strength and functional capacity. Studies on healthy individuals and various groups of patients show that resistance training in combination with protein and creatine ingestion is an effective means of increasing muscle mass, strength and functional capacity. Thus the aim is to investigate the following: is resistance training and dietary supplements tolerable among head and neck cancer patients the effect of the intervention on muscle mass, strength and functional capacity

Official Title
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A Randomized Trial Evaluating Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients

Conditions
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Head and Neck Neoplasms

Intervention / Treatment
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* Other: Resistance training
* Dietary Supplement: Protein and creatine
* Dietary Supplement: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: head and neck cancer patients (localized to the larynx, pharynx and oral cavity) treated with curative radiotherapy complete loss of tumor WHO performance status between 0-1 and expected ability to complete the training protocol No parenteral feeding above the age of 18 written concent Exclusion Criteria: other malignant diseases pregnancy undergoing systematic resistance training or creatin ingestion Alcohol abuse

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: resistance training and dietary supplement<br> | Other: Resistance training<br>* 12 weeks of resistance training in combination with protein and creatine or placebo ingestion<br>Dietary Supplement: Protein and creatine<br>* 30 g of protein with each training session, 5 g of creatine pr day<br>* Other names: In2Zyme WP80 and In2Zyme Biodrive 1;|
| Placebo Comparator: Resistance training and placebo ingestion<br>12 weeks of resistance training and placebo ingestion | Other: Resistance training<br>* 12 weeks of resistance training in combination with protein and creatine or placebo ingestion<br>Dietary Supplement: Placebo<br>* Maltodextrine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle mass and muscle strength |  | 13 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional capacity |  | 13 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Head and Neck Neoplasms, Resistance training, Muscle mass, Functional capacity