Clinical trial NCT05890859: Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation
Official title: Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Head and Neck Cancer Patients
Lean Body Mass
Body Composition Changes
Keywords: lean body mass
body composition
muscle strength
functional performance
cisplatin
head and neck cancer
Lead sponsor: Department of Public Health, Denmark
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Eligibility criteria: 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

Primary outcomes:
measure: Lean body mass
timeFrame: Bi-weekly from treatment start to two weeks post treatment (5 scans in total)
Secondary outcomes:
measure: Fat mass
timeFrame: Bi-weekly from treatment start to two weeks post treatment (5 scans in total)
Other outcomes:
measure: Maximal muscle strength
timeFrame: Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
measure: Stair climb performance
timeFrame: Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
measure: Arm curl performance
timeFrame: Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
measure: Chair rise performance
timeFrame: Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
Locations:
city: Odense C
country: Denmark
facility: Odense University Hospital
state: Southern Denmark Region
Study officials:
affiliation: University of Aarhus
name: Simon Lønbro, PhD
role: PRINCIPAL_INVESTIGATOR
References: