Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2026-01-21 @ 7:55 PM
Study NCT ID:
NCT05890859
Status:
COMPLETED
Last Update Posted:
2023-06-06
First Post:
2023-05-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation
Sponsor:
Department of Public Health, Denmark
Organization:
Study Overview
Official Title:
Lean Body Mass in Head and Neck Cancer Patients During Cisplatin-based Chemoradiation
Status:
COMPLETED
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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).
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).
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: