Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation

Study Overview
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Brief Summary
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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
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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).

Official Title
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Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation

Conditions
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Head and Neck Cancer Patients, Lean Body Mass, Body Composition Changes

Intervention / Treatment
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* Diagnostic Test: DXA scan
* Behavioral: Physical testing


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: DXA scans and physical tests<br>All patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment | Diagnostic Test: DXA scan<br>* The patients will undergo 5 DXA scans fro pre- to post treatment<br>Behavioral: Physical testing<br>* The patients will undergo tests for maximal muscle strength and functional performance before and after treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lean body mass | Lean body mass in kg determined by DXA scans | Bi-weekly from treatment start to two weeks post treatment (5 scans in total) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fat mass | FAt mass in kg measured by DXA scans | Bi-weekly from treatment start to two weeks post treatment (5 scans in total) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lean body mass, body composition, muscle strength, functional performance, cisplatin, head and neck cancer