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Clinical Trials/NCT01025518
NCT01025518
Completed
Not Applicable

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

Danish Head and Neck Cancer Group2 sites in 1 country30 target enrollmentSeptember 2009

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Head and Neck Neoplasms
Sponsor
Danish Head and Neck Cancer Group
Enrollment
30
Locations
2
Primary Endpoint
Muscle mass and muscle strength
Status
Completed
Last Updated
9 years ago

Overview

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

Registry
clinicaltrials.gov
Start Date
September 2009
End Date
January 2012
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Jens Overgaard

Professor, MD

Danish Head and Neck Cancer Group

Eligibility Criteria

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

Outcomes

Primary Outcomes

Muscle mass and muscle strength

Time Frame: 13 weeks

Secondary Outcomes

  • Functional capacity(13 weeks)

Study Sites (2)

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