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

Sarcopenia Clinical Trial

— SARVADS 1  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04804852
• Other study ID #: WP-2020-04
• Status: Recruiting
• Start date: October 29, 2020
• Est. completion date: May 30, 2022

Study information

• Verified date: March 2021
• Source: Weprom
• Contact: Magali BALAVOINE
• Phone: 241682940
• Email: m.balavoine[@]weprom.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 30, 2022
• Est. primary completion date: May 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cancer of Head and Neck
• CT Scan
• Head and Neck Neoplasms
• Sarcopenia

Intervention

Other:
• sarcopenia assessment
evaluation of sarcopenia by CT san at the C3 vertebrae

Locations

Country	Name	City	State
France	Clinique Victor Hugo / Centre Jean Bernard	Le Mans

Sponsors (1)

Lead Sponsor	Collaborator
Weprom

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessment of the prevalence of sarcopenia by cervical CT scan (C3)	Number of patients with sarcopenia at diagnosis and during treatments	6 months
Secondary	Assessment of hypoalbuminemia	Number of patients presenting an hypoalbuminemia.	6 month
Secondary	De- and undernutrition	Number of patients with a BMI <18 and with a prescription for nutritional complements.	6 month
Secondary	Compliance to the treatment	Number of patients having the complete planned treatment	6 months
Secondary	complete response rate	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	6 months
Secondary	Assessment of hospitalizations treatment-related complications	Number of hospitalizations per patient for treatment-related complications	6 months