Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Cancer

NCT ID: NCT04804852

Last Updated: 2021-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-29

Study Completion Date

2022-05-30

Brief Summary

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Sarcopenia is defined by the reduction in skeletal muscle mass and physical performance. It results in a decrease in muscle strength, overall physical activity, walking and the development of balance disorders and falls. It is one of the natural consequences of aging and contributes to frailty and the appearance of geriatric syndrome (s) (Chandapasirt et al, 2015; Cruz-Jentoft et al, 2010).

Its prevalence in patients with Head \& Neck cancer is 39% (Hua et al, 2020) and is associated with an increase in postoperative complications (Achim et al, 2017; Bril et al, 2019), with greater toxicity of chemotherapy. (Wendrich et al, 2017) and reduced overall survival (Hua et al, 2020).

It is measured by CT scan (assessment of muscle volume with respect to L3 using IMAGE J software) (Teigen et al, 2018) and by clinical tests (performance tests) (Swartz et al, 2016, Cruz-Jentoft et al, 2010).

Several studies have shown a possible assessment of sarcopenia by measuring skeletal muscle mass with regard to C3 (Ufuk et al, 2019; Swartz et al, 2016).

This trial aims to evaluate the prevalence of sarcopenia in head and neck cancer evaluated by CT at C3.

Detailed Description

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Conditions

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Sarcopenia Cancer of Head and Neck CT Scan

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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study population

Patient diagnosed with head \& neck carcinoma at diagnosis

sarcopenia assessment

Intervention Type OTHER

evaluation of sarcopenia by CT san at the C3 vertebrae

Interventions

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sarcopenia assessment

evaluation of sarcopenia by CT san at the C3 vertebrae

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* patient over 18 years old,
* affiliated to the social security scheme,
* suffering from locally advanced head \& neck cancer (stages I to IVB) at diagnosis,
* not operable,
* justifying treatment by radiotherapy, whether or not associated with chemotherapy or targeted therapy (eg: monoclonal antibodies, immunotherapy) whatever the proposed modalities.

Exclusion Criteria

* patient treated by non-conservative surgery and cervical lymph node dissection making it impossible to assess muscle mass with regard to C3,
* metastatic disease,
* minor patient,
* adult patient under guardianship,
* pregnancy or breastfeeding in progress.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Weprom

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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LE DU Katell, MD

Role: STUDY_DIRECTOR

Weprom

Locations

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Clinique Victor Hugo / Centre Jean Bernard

Le Mans, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Magali BALAVOINE

Role: CONTACT

241682940 ext. 0033

Jonas DUBU

Role: CONTACT

Facility Contacts

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Jonas DUBU

Role: primary

+33 769510938

Other Identifiers

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WP-2020-04

Identifier Type: -

Identifier Source: org_study_id

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