Head and Neck CancerNCT01509430
DAHANCA 25B: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC
A study testing Progressive Resistance Exercise Training in people with Head and Neck Cancer, run by Danish Head and Neck Cancer Group at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Progressive Resistance Exercise Training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Oct 2011to Apr 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 11Show fewer
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial
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.
- Conditions
- Head and Neck Cancer
- Being tested
- Progressive Resistance Exercise Training
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Progressive Resistance Exercise TrainingOther
12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training
Progressive Resistance Exercise TrainingOther
12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training
| Study group | Role | What they receive |
|---|---|---|
| Early training patient | Experimental | 12 weeks of Progressive Resistance Training followed by 12 weeks of a self chosen level of physical activity Receives: Other: Progressive Resistance Exercise Training |
| Late training patients | Experimental | 12 weeks of a self chosen level of physical activity followed by 12 weeks of progressive resistance training Receives: Other: Progressive Resistance Exercise Training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body composition
Lean body mass and fat mass assessed by DEXA scanning
Measured: Baseline, 3 months and 6 months
Secondary outcomes (8)
Maximal muscle strength
Isometric and isokinetic muscle dynamometry
Measured: Baseline, 3 months and 6 months
Maximal gait speed
10 m walk time
Measured: Baseline, 3 months and 6 months
Patient reported outcomes
Questionaires on Quality of Life, Fatigue and Mood
Measured: Baseline, 3 months and 6 months
Blood sampling
Investigation of changes in serum level of markers related to weight loss, inflammation and muscle hypertrophy
Measured: Baseline, 3 months and 6 months
30 s arm curl capacity
Measured: Baseline, 3 months, 6 months
Stair climbing capacity
Measured: Baseline, 3 months, 6 months
Jumping capacity
Counter Movement Jumps
Measured: Baseline, 3 months, 6 months
Chair rise capacity
30 s chair rise
Measured: Baseline, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2012 (estimated)
- Study startOct 2011
- Primary completionApr 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Head and Neck Cancer Group
- Sponsor type
- Research network
- Responsible party
- Principal investigator, Jens Overgaard, Danish Head and Neck Cancer Group
- Investigators
- Jens Overgaard, Prof., MD, Principal investigator, Danish Head and Neck Cancer Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01509430
- Sponsor's protocol ID
- DAHANCA 25B
- Status last verified
- Nov 2016
- First submitted
- 3 Jan 2012
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Progressive Resistance Training as Intervention for Regaining Muscle Mass After Radiation Therapy in Patients With HNSCC - a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01509430
- Acronym / sponsor ID
- DAHANCA 25B
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Danish Head and Neck Cancer GroupResearch network
- Study start
- Oct 2011
- Primary completion
- Apr 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 13 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early training patient | Experimental | Other: Progressive Resistance Exercise Training12 weeks of Progressive Resistance Training followed by 12 weeks of a self chosen level of physical activity |
| Late training patients | Experimental | Other: Progressive Resistance Exercise Training12 weeks of a self chosen level of physical activity followed by 12 weeks of progressive resistance training |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Progressive Resistance Exercise Training12 weeks of Progressive Resistance Exercise Training followed by 12 weeks of self chosen training | Other | Early training patient |
| Progressive Resistance Exercise Training12 weeks of self chosen training followed by 12 weeks of progressive resistance exercise training | Other | Late training patients |
Primary outcome
Body composition
Time frame: Baseline, 3 months and 6 months
Lean body mass and fat mass assessed by DEXA scanning
8 secondary outcomes
Maximal muscle strength
Time frame: Baseline, 3 months and 6 months
Maximal gait speed
Time frame: Baseline, 3 months and 6 months
Patient reported outcomes
Time frame: Baseline, 3 months and 6 months
Blood sampling
Time frame: Baseline, 3 months and 6 months
30 s arm curl capacity
Time frame: Baseline, 3 months, 6 months
Stair climbing capacity
Time frame: Baseline, 3 months, 6 months
Jumping capacity
Time frame: Baseline, 3 months, 6 months
Chair rise capacity
Time frame: Baseline, 3 months, 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- The website for the Danish Head and Neck Cancer Group (DAHANCA).Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jens Overgaard, Prof., MD principal investigator
Danish Head and Neck Cancer Group
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Progressive Resistance Exercise Training in people with Head and Neck Cancer, run by Danish Head and Neck Cancer Group at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body composition (time frame: Baseline, 3 months and 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016; AzTrials last refreshed its copy on 6 Nov 2026.