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

• Conditions: CT Scan; Sarcopenia; Cancer of Head and Neck
• Interventions: Other: sarcopenia assessment

• Registration Number: NCT04804852
• Lead Sponsor: Weprom

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-10-29
• Status Verified: 2021-03
• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-16
• Study First Posted: 2021-03-18
• Last Update Submitted: 2021-10-07
• Last Update Posted: 2021-10-08
• Primary Completion: 2022-05-30
• Study Completion: 2022-05-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
study population	sarcopenia assessment	Patient diagnosed with head \& neck carcinoma at diagnosis

Primary Outcome Measures

Name	Time	Method
Assessment of the prevalence of sarcopenia by cervical CT scan (C3)	6 months	Number of patients with sarcopenia at diagnosis and during treatments

Secondary Outcome Measures

Name	Time	Method
Assessment of hypoalbuminemia	6 month	Number of patients presenting an hypoalbuminemia.
De- and undernutrition	6 month	Number of patients with a BMI \<18 and with a prescription for nutritional complements.
Assessment of hospitalizations treatment-related complications	6 months	Number of hospitalizations per patient for treatment-related complications
Compliance to the treatment	6 months	Number of patients having the complete planned treatment
complete response rate	6 months	Number of patients with a complete response on the end-of-treatment evaluation scanner according to the RECIST or PERCIST criteria in the numerator out of the total number of patients in the denominator

Trial Locations

Locations (1)

Clinique Victor Hugo / Centre Jean Bernard; 🇫🇷 Le Mans, France