Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT05890859 |
Other study ID # |
LBM in HNSCC during treatment |
Secondary ID |
|
Status |
Completed |
Phase |
N/A
|
First received |
|
Last updated |
|
Start date |
April 5, 2015 |
Est. completion date |
May 15, 2023 |
Study information
Verified date |
May 2023 |
Source |
Department of Public Health, Denmark |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical 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 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.
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).