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

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.

Study Overview

• Status: Completed
• Conditions: Body Composition Changes; Lean Body Mass; Head and Neck Cancer Patients
• Intervention / Treatment: Diagnostic test: DXA scan; Behavioral: Physical testing

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 Type: Interventional
• Enrollment (Actual): 48
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Southern Denmark Region
    • Odense C, Southern Denmark Region, Denmark, 5000
      • Odense University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: DXA scans and physical tests; All patients are allocated to this arm and will undergod DXA scans and physical testing in addition to usual care/treatment	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Department of Public Health, Denmark
• Investigators: Principal Investigator: Simon Lønbro, PhD, University of Aarhus

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2015
• Primary Completion (Actual): July 31, 2017
• Study Completion (Actual): May 15, 2023

Study Registration Dates

• First Submitted: May 16, 2023
• First Submitted That Met QC Criteria: May 25, 2023
• First Posted (Actual): June 6, 2023

Study Record Updates

• Last Update Posted (Actual): June 6, 2023
• Last Update Submitted That Met QC Criteria: May 25, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: cisplatin; muscle strength; functional performance; body composition; head and neck cancer; lean body mass
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: LBM in HNSCC during treatment

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No