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

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ClinicalTrials.gov Identifier: NCT01025518
Recruitment Status : Completed
First Posted : December 3, 2009
Last Update Posted : November 29, 2016
Sponsor:
Collaborator:
Danish Center for Interventional Research in Radiation Oncology (CIRRO)
Information provided by (Responsible Party):
Jens Overgaard, Danish Head and Neck Cancer Group

Study Description
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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.

Condition or disease Intervention/treatment Phase
Head and Neck Neoplasms Other: Resistance training Dietary Supplement: Protein and creatine Dietary Supplement: Placebo Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomized Trial Evaluating Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
Study Start Date : September 2009
Actual Primary Completion Date : January 2012
Actual Study Completion Date : January 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Muscle mass and muscle strength [ Time Frame: 13 weeks ]

Secondary Outcome Measures :
  1. Functional capacity [ Time Frame: 13 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01025518


Locations
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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
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Study Chair: Jens Overgaard, Professor, MD DAHANCA
More Information
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Additional Information:

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Responsible Party: Jens Overgaard, Professor, MD, Danish Head and Neck Cancer Group
ClinicalTrials.gov Identifier: NCT01025518    
Other Study ID Numbers: DAHANCA 25A
CIRRO-IP010309 ( Other Grant/Funding Number: CIRRO )
Ethical Comittee: 20090181
First Posted: December 3, 2009    Key Record Dates
Last Update Posted: November 29, 2016
Last Verified: November 2016
Keywords provided by Jens Overgaard, Danish Head and Neck Cancer Group:
Head and Neck Neoplasms
Resistance training
Muscle mass
Functional capacity
Additional relevant MeSH terms:
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Head and Neck Neoplasms
Neoplasms
Neoplasms by Site