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

This study has been completed.
Sponsor:
Collaborator:
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Information provided by (Responsible Party):
Jens Overgaard, Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier:
NCT01025518
First received: December 2, 2009
Last updated: January 3, 2012
Last verified: January 2012
  Purpose

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.


Condition Intervention
Head and Neck Neoplasms
Other: Resistance training
Dietary Supplement: Protein and creatine
Dietary Supplement: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Trial Evaluationg Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by Danish Head and Neck Cancer Group:

Primary Outcome Measures:
  • Muscle mass and muscle strength [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functional capacity [ Time Frame: 13 weeks ] [ Designated as safety issue: No ]

Enrollment: 30
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: resistance training and dietary supplement Other: Resistance training
12 weeks of resistance training in combination with protein and creatine or placebo ingestion
Dietary Supplement: Protein and creatine
30 g of protein with each training session, 5 g of creatine pr day
Other Name: In2Zyme WP80 and In2Zyme Biodrive 1
Placebo Comparator: Resistance training and placebo ingestion
12 weeks of resistance training and placebo ingestion
Other: Resistance training
12 weeks of resistance training in combination with protein and creatine or placebo ingestion
Dietary Supplement: Placebo
Maltodextrine

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01025518

Locations
Denmark
Dept. of Experimental Clinical Oncology, Aarhus University Hospital
Aarhus, Region Midt, Denmark, 8000
Dept. of Experimental Clinical Oncology
Aarhus, Denmark, 8000
Sponsors and Collaborators
Danish Head and Neck Cancer Group
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Investigators
Study Chair: Jens Overgaard, Professor, MD DAHANCA
  More Information

Additional Information:
No publications provided

Responsible Party: Jens Overgaard, Professor, MD, Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier: NCT01025518     History of Changes
Other Study ID Numbers: DAHANCA 25, CIRRO‐IP010309, Ethical Comittee: 20090181
Study First Received: December 2, 2009
Last Updated: January 3, 2012
Health Authority: Denmark: The Danish National Committee on Biomedical Research Ethics

Keywords provided by Danish Head and Neck Cancer Group:
Head and Neck Neoplasms
Resistance training
Muscle mass
Functional capacity

Additional relevant MeSH terms:
Head and Neck Neoplasms
Neoplasms
Neoplasms by Site

ClinicalTrials.gov processed this record on October 23, 2014