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

Not Applicable

Completed

• Conditions: Head and Neck Neoplasms
• Interventions: Other: Resistance training; Dietary Supplement: Protein and creatine; Dietary Supplement: Placebo

• Registration Number: NCT01025518
• Lead Sponsor: Danish Head and Neck Cancer Group

Brief Summary

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

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

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-12-02
• Study First Submitted QC: 2009-12-02
• Study First Posted: 2009-12-03
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
resistance training and dietary supplement	Resistance training	-
resistance training and dietary supplement	Protein and creatine	-
Resistance training and placebo ingestion	Placebo	12 weeks of resistance training and placebo ingestion
Resistance training and placebo ingestion	Resistance training	12 weeks of resistance training and placebo ingestion

Primary Outcome Measures

Name	Time	Method
Muscle mass and muscle strength	13 weeks

Secondary Outcome Measures

Name	Time	Method
Functional capacity	13 weeks

Trial Locations

Locations (2)

Dept. of Experimental Clinical Oncology, Aarhus University Hospital; 🇩🇰 Aarhus, Region Midt, Denmark

Dept. of Experimental Clinical Oncology; 🇩🇰 Aarhus, Denmark