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Completed

NCT Number: NCT01025518

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

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.

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Key information

Conditions

Head and Neck Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Resistance training

Other

12 weeks of resistance training in combination with protein and creatine or placebo ingestion

Protein and creatine

Dietary Supplement

30 g of protein with each training session, 5 g of creatine pr day

Other names: In2Zyme WP80 and In2Zyme Biodrive 1

Placebo

Dietary Supplement

Maltodextrine

Primary outcomes

  1. Muscle mass and muscle strength

    Time frame: 13 weeks

Secondary outcomes

  1. Functional capacity

    Time frame: 13 weeks

Sponsors and collaborators

Lead sponsor

Danish Head and Neck Cancer Group

Network

Collaborators

  • Danish Center for Interventional Research in Radiation Oncology (CIRRO)

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Dec 3, 2009
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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