Back to resultsDAHANCA 25B: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC
Primary Purpose
Head and Neck Cancer
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Progressive Resistance Exercise Training
Progressive Resistance Exercise Training
Sponsored by
About this trial
This is an interventional supportive care trial for Head and Neck Cancer
Eligibility Criteria
Inclusion Criteria:
- Histologically diagnosed with squamous cell carcinomas of the larynx (no glottis stage I+II), pharynx, oral cavity or in lymph nodes from an unknown primary tumour (stage I-IV and tumour node metastasis (TNM) classification, UICC, Geneva, 1987)
- Terminated curative radiotherapy treatment with/without chemotherapy;
- No metastases
- Complete tumour remission
- No current or previous malignancies that could prevent participation and training
- No excessive alcohol intake (men > 21 and women > 14 units/wk)
- No recent systematic resistance training or creatine ingestion (within 2 months)
- If woman, not pregnant
- WHO performance status of 0-1
- No psychological, social or geographical conditions that could disturb participation
- Written consent
Sites / Locations
- Dept. of Experimental Clinical Oncology
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Early training patient
Late training patients
Arm Description
12 weeks of Progressive Resistance Training followed by 12 weeks of a self chosen level of physical activity
12 weeks of a self chosen level of physical activity followed by 12 weeks of progressive resistance training
Outcomes
Primary Outcome Measures
Body composition
Lean body mass and fat mass assessed by DEXA scanning
Secondary Outcome Measures
Maximal muscle strength
Isometric and isokinetic muscle dynamometry
Maximal gait speed
10 m walk time
Patient reported outcomes
Questionaires on Quality of Life, Fatigue and Mood
Blood sampling
Investigation of changes in serum level of markers related to weight loss, inflammation and muscle hypertrophy
30 s arm curl capacity
Stair climbing capacity
Jumping capacity
Counter Movement Jumps
Chair rise capacity
30 s chair rise
Full Information
NCT ID
NCT01509430
First Posted
January 3, 2012
Last Updated
November 28, 2016
Sponsor
Danish Head and Neck Cancer Group
1. Study Identification
Unique Protocol Identification Number
NCT01509430
Brief Title
DAHANCA 25B: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC
Official Title
Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
April 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Danish Head and Neck Cancer Group
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Head and neck cancer patients often experience a critical weight loss of around 10% following radiation therapy. Of this up to 70% is muscle mass and is an independent predictor of mortality, lowers muscle strength and functional performance. The purpose of this study is in a randomized controlled trial to investigate the effects of progressive resistance training (PRET) on changes in muscle mass, muscle strength and functional performance in head and neck cancer survivors. The investigators hypothesize that PRET has a positive effect on all primary endpoints and increases muscle mass, muscle strength and functional performance.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Head and Neck Cancer
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
41 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Early training patient
Arm Type
Experimental
Arm Description
12 weeks of Progressive Resistance Training followed by 12 weeks of a self chosen level of physical activity
Arm Title
Late training patients
Arm Type
Experimental
Arm Description
12 weeks of a self chosen level of physical activity followed by 12 weeks of progressive resistance training
Intervention Type
Other
Intervention Name(s)
Progressive Resistance Exercise Training
Intervention Description
12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training
Intervention Type
Other
Intervention Name(s)
Progressive Resistance Exercise Training
Intervention Description
12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training
Primary Outcome Measure Information:
Title
Body composition
Description
Lean body mass and fat mass assessed by DEXA scanning
Time Frame
Baseline, 3 months and 6 months
Secondary Outcome Measure Information:
Title
Maximal muscle strength
Description
Isometric and isokinetic muscle dynamometry
Time Frame
Baseline, 3 months and 6 months
Title
Maximal gait speed
Description
10 m walk time
Time Frame
Baseline, 3 months and 6 months
Title
Patient reported outcomes
Description
Questionaires on Quality of Life, Fatigue and Mood
Time Frame
Baseline, 3 months and 6 months
Title
Blood sampling
Description
Investigation of changes in serum level of markers related to weight loss, inflammation and muscle hypertrophy
Time Frame
Baseline, 3 months and 6 months
Title
30 s arm curl capacity
Time Frame
Baseline, 3 months, 6 months
Title
Stair climbing capacity
Time Frame
Baseline, 3 months, 6 months
Title
Jumping capacity
Description
Counter Movement Jumps
Time Frame
Baseline, 3 months, 6 months
Title
Chair rise capacity
Description
30 s chair rise
Time Frame
Baseline, 3 months, 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Histologically diagnosed with squamous cell carcinomas of the larynx (no glottis stage I+II), pharynx, oral cavity or in lymph nodes from an unknown primary tumour (stage I-IV and tumour node metastasis (TNM) classification, UICC, Geneva, 1987)
Terminated curative radiotherapy treatment with/without chemotherapy;
No metastases
Complete tumour remission
No current or previous malignancies that could prevent participation and training
No excessive alcohol intake (men > 21 and women > 14 units/wk)
No recent systematic resistance training or creatine ingestion (within 2 months)
If woman, not pregnant
WHO performance status of 0-1
No psychological, social or geographical conditions that could disturb participation
Written consent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jens Overgaard, Prof., MD
Organizational Affiliation
Danish Head and Neck Cancer Group
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dept. of Experimental Clinical Oncology
City
Aarhus C
ZIP/Postal Code
8000
Country
Denmark
12. IPD Sharing Statement
Links:
URL
http://www.dahanca.dk/
Description
The website for the Danish Head and Neck Cancer Group (DAHANCA).
Learn more about this trial
DAHANCA 25B: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC
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