Head and Neck Cancer Patients, Lean Body Mass, Body Composition Changes
Conditions
Keywords
lean body mass, body composition, muscle strength, functional performance, cisplatin, head and neck cancer
Brief 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 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).
Interventions
DIAGNOSTIC_TESTDXA scan
The patients will undergo 5 DXA scans fro pre- to post treatment
BEHAVIORALPhysical testing
The patients will undergo tests for maximal muscle strength and functional performance before and after treatment
Sponsors
Department of Public Health, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* Palliative radiation or participation in competing research protocols
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Lean body mass | Bi-weekly from treatment start to two weeks post treatment (5 scans in total) | Lean body mass in kg determined by DXA scans |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Fat mass | Bi-weekly from treatment start to two weeks post treatment (5 scans in total) | FAt mass in kg measured by DXA scans |
Other
| Measure | Time frame | Description |
|---|---|---|
| Maximal muscle strength | Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end) | One repetition maximum in knee extension (unilateral), leg press (unilateral) and chest press (bilateral) |
| Stair climb performance | Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end) | The fastest walking/running time in a stair climb test is recorded (two flights of stairs) |
| Arm curl performance | Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end) | The maximum number of repetitions in 30 s arm curl test are recorded |
| Chair rise performance | Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end) | The maximum number of repetitions in 30 s chair rise test are recorded |
Countries
Denmark
Outcome results
None listed