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

Not Applicable

Completed

• Conditions: Head and Neck Cancer Patients; Body Composition Changes; Lean Body Mass
• Interventions: Diagnostic Test: DXA scan; Behavioral: Physical testing

• Registration Number: NCT05890859
• Lead Sponsor: Department of Public Health, Denmark

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).

Study Timeline

• Study Start: 2015-04-05
• Primary Completion: 2017-07-31
• Status Verified: 2023-05
• Study Completion: 2023-05-15
• Study First Submitted: 2023-05-16
• Study First Submitted QC: 2023-05-25
• Last Update Submitted: 2023-05-25
• Study First Posted: 2023-06-06
• Last Update Posted: 2023-06-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
DXA scans and physical tests	DXA scan	All patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment
DXA scans and physical tests	Physical testing	All patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment

Primary Outcome Measures

Name	Time	Method
Lean body mass	Bi-weekly from treatment start to two weeks post treatment (5 scans in total)	Lean body mass in kg determined by DXA scans

Secondary Outcome Measures

Name	Time	Method
Fat mass	Bi-weekly from treatment start to two weeks post treatment (5 scans in total)	FAt mass in kg measured by DXA scans

Trial Locations

Locations (1)

Odense University Hospital; 🇩🇰 Odense C, Southern Denmark Region, Denmark