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

NCT04804852 | Unknown

• 1 other identifier: WP-2020-04
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Sarcopenia; Cancer of Head and Neck; CT Scan

Outcome Measures

Primary Outcomes (1)

• Assessment of the prevalence of sarcopenia by cervical CT scan (C3)

  Number of patients with sarcopenia at diagnosis and during treatments

  6 months

Secondary Outcomes (5)

• Assessment of hypoalbuminemia

  6 month

• De- and undernutrition

  6 month

• Compliance to the treatment

  6 months

• complete response rate

  6 months

• Assessment of hospitalizations treatment-related complications

  6 months

Study Arms (1)

study population

Patient diagnosed with head \& neck carcinoma at diagnosis

Other: sarcopenia assessment

Interventions

sarcopenia assessment OTHER

evaluation of sarcopenia by CT san at the C3 vertebrae

study population

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patient diagnosed with head \& neck carcinoma non operable and treated by radiotherapy and/or chemotherapy and/or targeted therapy.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Weprom: lead

Study Sites (1)

Clinique Victor Hugo / Centre Jean Bernard

Le Mans, 72000, France

RECRUITING

MeSH Terms

Conditions

Sarcopenia; Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Neoplasms by Site; Neoplasms

Study Officials

• LE DU Katell, MD

  Weprom

  STUDY DIRECTOR

Central Study Contacts

Magali BALAVOINE

CONTACT

241682940; m.balavoine@weprom.fr

Jonas DUBU

CONTACT

jonas.dubu@i-l-c.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: October 29, 2020
• Primary Completion: May 30, 2022
• Study Completion: May 30, 2022
• Last Updated: October 8, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)