Head and Neck NeoplasmsNCT01025518
DAHANCA 25A: Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
A study testing Resistance training and Protein and creatine in people with Head and Neck Neoplasms, run by Danish Head and Neck Cancer Group at 2 sites in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Resistance training and Protein and creatine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 2 sitesDenmark
- Study dates
- Sep 2009to Jan 2012
- 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
- 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
Who cannot join
- other malignant diseases
- pregnancy
- undergoing systematic resistance training or creatin ingestion
- Alcohol abuse
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Dept. of Experimental Clinical Oncology, Aarhus University Hospital
Aarhus, Region Midt, 8000
Dept. of Experimental Clinical Oncology
Aarhus, 8000
About this study
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
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.
Read the 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
- Conditions
- Head and Neck Neoplasms
- Being tested
- Resistance training, Protein and creatine, Placebo
- Keywords
- Head and Neck Neoplasms, Resistance training, Muscle mass, Functional capacity
- 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.
Resistance trainingOther
12 weeks of resistance training in combination with protein and creatine or placebo ingestion
Protein and creatineDietary supplement
Also called In2Zyme WP80 and In2Zyme Biodrive 1
30 g of protein with each training session, 5 g of creatine pr day
PlaceboDietary supplement
Maltodextrine
| Study group | Role | What they receive |
|---|---|---|
| resistance training and dietary supplement | Experimental | Not described Receives: Other: Resistance training; Dietary Supplement: Protein and creatine |
| Resistance training and placebo ingestion | Placebo comparator | 12 weeks of resistance training and placebo ingestion Receives: Other: Resistance training; Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle mass and muscle strength
Measured: 13 weeks
Secondary outcomes (1)
Functional capacity
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2009 (estimated)
- Study startSep 2009
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies 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
- Participant, Outcomes assessor
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Danish Head and Neck Cancer Group
- Sponsor type
- Research network
- Collaborators
- Danish Center for Interventional Research in Radiation Oncology (CIRRO)
- Responsible party
- Principal investigator, Jens Overgaard, Danish Head and Neck Cancer Group
- Investigators
- Jens Overgaard, Professor, MD, Study chair, DAHANCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01025518
- Sponsor's protocol ID
- DAHANCA 25A
- Other IDs
- CIRRO-IP010309, Ethical Comittee: 20090181
- Status last verified
- Nov 2016
- First submitted
- 2 Dec 2009
- 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
- A Randomized Trial Evaluating Resistance Training and Dietary Supplements as Intervention for Regaining Muscle Mass Following Radiotherapy in Head and Neck Cancer Patients
- ClinicalTrials.gov ID
- NCT01025518
- Acronym / sponsor ID
- DAHANCA 25A
- Conditions
- Head and Neck Neoplasms
- Keywords
- Head and Neck Neoplasms, Resistance training, Muscle mass, Functional capacity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Danish Head and Neck Cancer GroupResearch network
- Collaborators
- Danish Center for Interventional Research in Radiation Oncology (CIRRO)
- Study start
- Sep 2009
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 3 Dec 2009 (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.
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.
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
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| resistance training and dietary supplement | Experimental | Other: Resistance training, Dietary Supplement: Protein and creatine |
| Resistance training and placebo ingestion | Placebo comparator | Other: Resistance training, Dietary Supplement: Placebo12 weeks of resistance training and placebo ingestion |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (4 listed)
- other malignant diseases
- pregnancy
- undergoing systematic resistance training or creatin ingestion
- Alcohol abuse
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 |
|---|---|---|
| Resistance training12 weeks of resistance training in combination with protein and creatine or placebo ingestion | Other | Resistance training and placebo ingestion, resistance training and dietary supplement |
| Protein and creatineAlso: In2Zyme WP80 and In2Zyme Biodrive 130 g of protein with each training session, 5 g of creatine pr day | Dietary supplement | resistance training and dietary supplement |
| PlaceboMaltodextrine | Dietary supplement | Resistance training and placebo ingestion |
Primary outcome
Muscle mass and muscle strength
Time frame: 13 weeks
1 secondary outcome
Functional capacity
Time frame: 13 weeks
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.
- Danish Head and Neck Cancer GroupLink 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, Professor, MD study chair
DAHANCA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training and Protein and creatine in people with Head and Neck Neoplasms, run by Danish Head and Neck Cancer Group at 2 sites 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 6 inclusion and 4 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 2 sites 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. Some participants in this study may receive a placebo. 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?
Muscle mass and muscle strength (time frame: 13 weeks). 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.