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

Lean Body Mass Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05890859
• Other study ID #: LBM in HNSCC during treatment
• Status: Completed
• Phase: N/A
• 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
• 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: May 15, 2023
• Est. primary completion date: July 31, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Head and Neck Cancer Patients
• Head and Neck Neoplasms
• Lean Body Mass

Intervention

Diagnostic Test:
• DXA scan
The patients will undergo 5 DXA scans fro pre- to post treatment

Behavioral:
• Physical testing
The patients will undergo tests for maximal muscle strength and functional performance before and after treatment

Locations

Country	Name	City	State
Denmark	Odense University Hospital	Odense C	Southern Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
Department of Public Health, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Maximal muscle strength	One repetition maximum in knee extension (unilateral), leg press (unilateral) and chest press (bilateral)	Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
Other	Stair climb performance	The fastest walking/running time in a stair climb test is recorded (two flights of stairs)	Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
Other	Arm curl performance	The maximum number of repetitions in 30 s arm curl test are recorded	Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
Other	Chair rise performance	The maximum number of repetitions in 30 s chair rise test are recorded	Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)
Primary	Lean body mass	Lean body mass in kg determined by DXA scans	Bi-weekly from treatment start to two weeks post treatment (5 scans in total)
Secondary	Fat mass	FAt mass in kg measured by DXA scans	Bi-weekly from treatment start to two weeks post treatment (5 scans in total)