Head and Neck Cancer Clinical Trial
Official title:
Feasibility of a 12-week Progressive Resistance Training Program in Head and Neck Cancer Patients During Concurrent Radiochemotherapy - a Pilot Trial
Verified date | September 2015 |
Source | Herlev Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Ethics Committee |
Study type | Interventional |
The purpose of this study is to evaluate the feasibility of a 12-week progressive resistance training (PRT) during concurrent chemoradiotherapy in head and neck cancer patients compared to usual care.
Status | Completed |
Enrollment | 12 |
Est. completion date | September 2015 |
Est. primary completion date | September 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - Patients with head and neck squamous cell carcinoma - Candidates for concomitant chemoradiotherapy according to Danish Head and Neck Cancer Group (DAHANCA) guidelines. - Performance status 0-1 - Expected to be able to complete the intervention, i.e. no major comorbidities or social issues that could compromise attendance. - At least 18 years of age. |
Intervention Model: Single Group Assignment, Masking: Open Label
Country | Name | City | State |
---|---|---|---|
Denmark | Dept. of Oncology | Herlev |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Muscle biopsies | In order to establish energy-reserves in the muscles | up to 7 months | No |
Other | Blood samples | In order to identify systemic factors released during exercise | Up to 20 months | No |
Primary | Feasibility | The feasibility outcomes will be inclusion rate defined as the number of patients recruited from the number of eligible patients and completion rate defined as the number of participants able to complete the intervention. Adherence to the exercise intervention will be evaluated via patient-reported training logs. |
up to 7 months | No |
Secondary | Change in LBM | Whole body LBM will be determined using dual energy x-ray absorptiometry (DXA). | up to 20 months | No |
Secondary | Weight loss | Patient will be weighed weekly during the 12-week PRT program; afterwards at each follow-up (2, 5, 9, and 13 months) | up to 20 months | No |
Secondary | Number of patients with side-effects to treatment | Side-effects will be registered using Common Terminology Criteria for Advers Events v4.0 (CTCAE). | up to 7 months | No |
Secondary | Quality of Life | Up to 20 months | No | |
Secondary | Change in physical function and strength | Change in muscle strength will be evaluated by 1 repetition maximum test (1RM) measured in kg. Change in muscle power will be evaluated by Nottingham Power Rig and measured in watts and watt/kg. Change in physical function will be evaluated by 30 second sit-to-stand test, arm curl test and stair climbing. |
Up to 20 months | No |
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