Lean Body Mass in Head and Neck Cancer Patients During Ci... | NCT05890859

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

NCT05890859

Sponsor

Department of Public Health, Denmark

Status

Completed

Last Update Posted

Jun 6, 2023Actual

Enrollment

48Actual

Phase

Not Applicable

Conditions

Head and Neck Cancer Patients
Lean Body Mass
Body Composition Changes

Interventions

DXA scan
Physical testing

Countries

Denmark

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 5, 2015Actual

Primary Completion Date

Jul 31, 2017Actual

Completion Date

May 15, 2023Actual

First Submitted Date

May 16, 2023

First Submission Date that Met QC Criteria

May 25, 2023

First Posted Date

Jun 6, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 25, 2023

Last Update Posted Date

Jun 6, 2023Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Simon Lønbro, PhD, Department of Public Health, DenmarkPrincipal Investigator

Lead Sponsor

Department of Public Health, DenmarkOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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 scan Behavioral: Physical testing

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DXA scan	Diagnostic Test	The patients will undergo 5 DXA scans fro pre- to post treatment	DXA scans and physical tests

Outcomes Module

Primary Outcomes

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 Outcomes

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 Outcomes

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

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Simon Lønbro, PhD	University of Aarhus	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Odense University Hospital		Odense C	Southern Denmark Region	5000	Denmark

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
37589161	Derived	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.

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms

ID	Term
D015502	Absorptiometry, Photon
D005080	Exercise Test

ID	Term
D011859	Radiography
D003952	Diagnostic Imaging
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis