Head and Neck Cancer PatientsNCT05890859
Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation
A study testing DXA scan and Physical testing in people with Head and Neck Cancer Patients and Lean Body Mass, run by Department of Public Health, Denmark at 1 site in Denmark.
Trial summary
The goal of this clinical trial is to investigate the changes in body composition in head and neck cancer patients during treatment. The main questions it aims to answer are: What is the rate of lean body mass loss and how is it associated with changes in muscle strength and functional performance? Is the lean body… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer Patients, Lean Body Mass, Body Composition Changes
- What is being tested?
- DXA scan and Physical testing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteDenmark
- Study dates
- 5 Apr 2015to 15 May 2023
- 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 proven squamous cell carcinoma of the larynx, pharynx, or oral cavity
- Prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy
Who cannot join
- Palliative radiation or participation in competing research protocols
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Odense University Hospital
Odense C, Southern Denmark Region, 5000
About this study
The goal of this clinical trial is to investigate the changes in body composition in head and neck cancer patients during treatment. The main questions it aims to answer are: What is the rate of lean body mass loss and how is it associated with changes in muscle strength and functional performance? Is the lean body mass loss impacted by adding chemotherapy to the radiation treatment? Participants will be asked to undergo five body composition scans during treatment and undergo tests for muscle strength and functional performance before and after treatment.
Read the detailed description
The primary aim of the present study is to investigate the rate of decline in body composition (LBM, body weight and fat mass) as well as changes in maximal muscle strength and functional performance during radiation treatment in HNSCC patients and to investigate the association between the loss of LBM and impairments in maximal muscle strength and functional performance. Secondly, the study investigates whether adding cisplatin during chemoradiation induces exacerbated LBM loss compared to radiation alone.
50 patients are expected to be included in the study. Inclusion criteria are: (1) histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity, (2) prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy. Exclusion criteria were palliative radiation or participation in competing research protocols.
Five times during treatment (biweekly), patients will be asked to undergo a Dual Energy X-ray Absorptiometry scan to evaluate changes in lean body mass and fat mass. Before and after treatment patients are asked to perform three test for maximal muscle strength (one repetition maximum knee extension, chest press and leg press) as well as three functional performance test (30 s arm curl, 30 s chair rise and stair climb).
- Being tested
- DXA scan, Physical testing
- Keywords
- lean body mass, body composition, muscle strength, functional performance, cisplatin, head and neck cancer
- 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.
DXA scanDiagnostic test
The patients will undergo 5 DXA scans fro pre- to post treatment
Physical testingBehavioural
The patients will undergo tests for maximal muscle strength and functional performance before and after treatment
| Study group | Role | What they receive |
|---|---|---|
| DXA scans and physical tests | Other | All patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment Receives: Diagnostic Test: DXA scan; Behavioral: Physical testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lean body mass
Lean body mass in kg determined by DXA scans
Measured: Bi-weekly from treatment start to two weeks post treatment (5 scans in total)
Secondary outcomes (1)
Fat mass
FAt mass in kg measured by DXA scans
Measured: Bi-weekly from treatment start to two weeks post treatment (5 scans in total)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start5 Apr 2015
- Primary completion31 Jul 2017
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Head and Neck Cancer PatientsStudies 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Department of Public Health, Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Simon Lønbro, Department of Public Health, Denmark
- Investigators
- Simon Lønbro, PhD, Principal investigator, University of Aarhus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890859
- Sponsor's protocol ID
- LBM in HNSCC during treatment
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lonbro S, Gam S, Hermann AP, Hansen CR, Johansen J. Accelerated loss of lean body mass in head and neck cancer patients during cisplatin-based chemoradiation. Acta Oncol. 2023 Nov;62(11):1403-1411. doi: 10.1080/0284186X.2023.2245558. Epub 2023 Aug 17.
PubMed 37589161
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation
- ClinicalTrials.gov ID
- NCT05890859
- Acronym / sponsor ID
- LBM in HNSCC during treatment
- Keywords
- lean body mass, body composition, muscle strength, functional performance, cisplatin, head and neck cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Department of Public Health, DenmarkUniversity, hospital or other
- Study start
- 5 Apr 2015 (actual)
- Primary completion
- 31 Jul 2017 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 6 Jun 2023 (actual)
- 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 goal of this clinical trial is to investigate the changes in body composition in head and neck cancer patients during treatment. The main questions it aims to answer are: What is the rate of lean body mass loss and how is it associated with changes in muscle strength and functional performance? Is the lean body mass loss impacted by adding chemotherapy to the radiation treatment? Participants will be asked to undergo five body composition scans during treatment and undergo tests for muscle strength and functional performance before and after treatment.
Detailed description
The primary aim of the present study is to investigate the rate of decline in body composition (LBM, body weight and fat mass) as well as changes in maximal muscle strength and functional performance during radiation treatment in HNSCC patients and to investigate the association between the loss of LBM and impairments in maximal muscle strength and functional performance. Secondly, the study investigates whether adding cisplatin during chemoradiation induces exacerbated LBM loss compared to radiation alone.
50 patients are expected to be included in the study. Inclusion criteria are: (1) histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity, (2) prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy. Exclusion criteria were palliative radiation or participation in competing research protocols.
Five times during treatment (biweekly), patients will be asked to undergo a Dual Energy X-ray Absorptiometry scan to evaluate changes in lean body mass and fat mass. Before and after treatment patients are asked to perform three test for maximal muscle strength (one repetition maximum knee extension, chest press and leg press) as well as three functional performance test (30 s arm curl, 30 s chair rise and stair climb).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| DXA scans and physical tests | Other | Diagnostic Test: DXA scan, Behavioral: Physical testingAll patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Histologically proven squamous cell carcinoma of the larynx, pharynx, or oral cavity
- Prescribed to radical or post-operative radiotherapy of at least 60 Gy with or without concomitant chemotherapy
Key exclusion criteria (1 listed)
- Palliative radiation or participation in competing research protocols
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 |
|---|---|---|
| DXA scanThe patients will undergo 5 DXA scans fro pre- to post treatment | Diagnostic test | DXA scans and physical tests |
| Physical testingThe patients will undergo tests for maximal muscle strength and functional performance before and after treatment | Behavioural | DXA scans and physical tests |
Primary outcome
Lean body mass
Time frame: Bi-weekly from treatment start to two weeks post treatment (5 scans in total)
Lean body mass in kg determined by DXA scans
1 secondary outcome
Fat mass
Time frame: Bi-weekly from treatment start to two weeks post treatment (5 scans in total)
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 6 Jun 2023.
- Derived from this study: PubMed 37589161Lonbro S, Gam S, Hermann AP, Hansen CR, Johansen J. Accelerated loss of lean body mass in head and neck cancer patients during cisplatin-based chemoradiation. Acta Oncol. 2023 Nov;62(11):1403-1411. doi: 10.1080/0284186X.2023.2245558. Epub 2023 Aug 17.
- Individual participant dataSharing planned: No
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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.
Simon Lønbro, PhD principal investigator
University of Aarhus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DXA scan and Physical testing in people with Head and Neck Cancer Patients and Lean Body Mass, run by Department of Public Health, Denmark 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 2 inclusion and 1 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 6 Jun 2023. 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?
Lean body mass (time frame: Bi-weekly from treatment start to two weeks post treatment (5 scans in total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05890859, which also lists 1 linked publication.
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 6 Jun 2023.