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

Primary Purpose

Head and Neck Cancer Patients, Lean Body Mass, Body Composition Changes

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
DXA scan
Physical testing
Sponsored by
Department of Public Health, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Head and Neck Cancer Patients focused on measuring lean body mass, body composition, muscle strength, functional performance, cisplatin, head and neck cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Odense University Hospital

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

DXA scans and physical tests

Arm Description

All patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment

Outcomes

Primary Outcome Measures

Lean body mass
Lean body mass in kg determined by DXA scans

Secondary Outcome Measures

Fat mass
FAt mass in kg measured by DXA scans

Full Information

First Posted
May 16, 2023
Last Updated
May 25, 2023
Sponsor
Department of Public Health, Denmark
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1. Study Identification

Unique Protocol Identification Number
NCT05890859
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
April 5, 2015 (Actual)
Primary Completion Date
July 31, 2017 (Actual)
Study Completion Date
May 15, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Department of Public Health, Denmark

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
DXA scans and physical tests
Arm Type
Other
Arm Description
All patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment
Intervention Type
Diagnostic Test
Intervention Name(s)
DXA scan
Intervention Description
The patients will undergo 5 DXA scans fro pre- to post treatment
Intervention Type
Behavioral
Intervention Name(s)
Physical testing
Intervention Description
The patients will undergo tests for maximal muscle strength and functional performance before and after treatment
Primary Outcome Measure Information:
Title
Lean body mass
Description
Lean body mass in kg determined by DXA scans
Time Frame
Bi-weekly from treatment start to two weeks post treatment (5 scans in total)
Secondary Outcome Measure Information:
Title
Fat mass
Description
FAt mass in kg measured by DXA scans
Time Frame
Bi-weekly from treatment start to two weeks post treatment (5 scans in total)
Other Pre-specified Outcome Measures:
Title
Maximal muscle strength
Description
One repetition maximum in knee extension (unilateral), leg press (unilateral) and chest press (bilateral)
Time Frame
Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
Title
Stair climb performance
Description
The fastest walking/running time in a stair climb test is recorded (two flights of stairs)
Time Frame
Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
Title
Arm curl performance
Description
The maximum number of repetitions in 30 s arm curl test are recorded
Time Frame
Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
Title
Chair rise performance
Description
The maximum number of repetitions in 30 s chair rise test are recorded
Time Frame
Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simon Lønbro, PhD
Organizational Affiliation
University of Aarhus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Odense University Hospital
City
Odense C
State/Province
Southern Denmark Region
ZIP/Postal Code
5000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
No

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

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