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Completed

NCT Number: NCT05890859

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

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.

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Key information

Conditions

Head and Neck Cancer Patients Body Composition Changes Head and Neck Neoplasms Lean Body Mass Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Odense University Hospital

Odense C, Southern Denmark Region, 5000, Denmark

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DXA scan

Diagnostic Test

The patients will undergo 5 DXA scans fro pre- to post treatment

Physical testing

Behavioral

The patients will undergo tests for maximal muscle strength and functional performance before and after treatment

Primary outcomes

  1. 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

Secondary outcomes

  1. Fat mass

    Time frame: Bi-weekly from treatment start to two weeks post treatment (5 scans in total)

    FAt mass in kg measured by DXA scans

Other outcomes

  1. Maximal muscle strength

    Time frame: 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)

  2. Stair climb performance

    Time frame: 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)

  3. Arm curl performance

    Time frame: 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

  4. Chair rise performance

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Department of Public Health, Denmark

Other

Registry information

Important dates

Study start
2015
Primary completion
2017
Study completion
2023
First posted
Jun 6, 2023
Registry last updated
Jun 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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