- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01025518
DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
A Randomized Trial Evaluating Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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-
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Aarhus, Denmark, 8000
- Dept. of Experimental Clinical Oncology
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Region Midt
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Aarhus, Region Midt, Denmark, 8000
- Dept. of Experimental Clinical Oncology, Aarhus University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: resistance training and dietary supplement
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12 weeks of resistance training in combination with protein and creatine or placebo ingestion
30 g of protein with each training session, 5 g of creatine pr day
Other Names:
|
Placebo Comparator: Resistance training and placebo ingestion
12 weeks of resistance training and placebo ingestion
|
12 weeks of resistance training in combination with protein and creatine or placebo ingestion
Maltodextrine
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Muscle mass and muscle strength
Time Frame: 13 weeks
|
13 weeks
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Functional capacity
Time Frame: 13 weeks
|
13 weeks
|
Collaborators and Investigators
Investigators
- Study Chair: Jens Overgaard, Professor, MD, DAHANCA
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- DAHANCA 25A
- CIRRO-IP010309 (Other Grant/Funding Number: CIRRO)
- Ethical Comittee: 20090181
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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