NCT05890859

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Apr 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 5, 2015

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
5.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2023

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

May 16, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

June 6, 2023

Completed
Last Updated

June 6, 2023

Status Verified

May 1, 2023

Enrollment Period

2.3 years

First QC Date

May 16, 2023

Last Update Submit

May 25, 2023

Conditions

Head and Neck Cancer PatientsLean Body MassBody Composition Changes

Keywords

lean body massbody compositionmuscle strengthfunctional performancecisplatinhead and neck cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Fat mass

    Bi-weekly from treatment start to two weeks post treatment (5 scans in total)

Other Outcomes (4)

  • Maximal muscle strength

    Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)

  • Stair climb performance

    Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)

  • Arm curl performance

    Before and after treatment (i.e. 2-3 days before treatment start and two weeks after treatment end)

  • +1 more other outcomes

Study Arms (1)

DXA scans and physical tests

OTHER

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

Diagnostic Test: DXA scanBehavioral: Physical testing

Interventions

DXA scanDIAGNOSTIC_TEST

The patients will undergo 5 DXA scans fro pre- to post treatment

DXA scans and physical tests
Physical testingBEHAVIORAL

The patients will undergo tests for maximal muscle strength and functional performance before and after treatment

DXA scans and physical tests

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Palliative radiation or participation in competing research protocols

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Odense University Hospital

Odense C, Southern Denmark Region, 5000, Denmark

Location

Related Publications (1)

  • Lonbro S, Gam S, Hermann AP, Hansen CR, Johansen J. Accelerated loss of lean body mass in head and neck cancer patients during cisplatin-based chemoradiation. Acta Oncol. 2023 Nov;62(11):1403-1411. doi: 10.1080/0284186X.2023.2245558. Epub 2023 Aug 17.

    PMID: 37589161DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms

Interventions

Absorptiometry, PhotonExercise Test

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Intervention Hierarchy (Ancestors)

RadiographyDiagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisDensitometryPhotometryChemistry Techniques, AnalyticalInvestigative TechniquesHeart Function TestsDiagnostic Techniques, CardiovascularRespiratory Function TestsDiagnostic Techniques, Respiratory SystemErgometry

Study Officials

  • Simon Lønbro, PhD

    University of Aarhus

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

May 16, 2023

First Posted

June 6, 2023

Study Start

April 5, 2015

Primary Completion

July 31, 2017

Study Completion

May 15, 2023

Last Updated

June 6, 2023

Record last verified: 2023-05

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)