Clinical trial NCT04804852: Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Cancer
Official title: Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Carcinoma
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Sarcopenia
Cancer of Head and Neck
CT Scan
Lead sponsor: Weprom
Sponsor class: OTHER
First posted: 2021-03-18
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of the prevalence of sarcopenia by cervical CT scan (C3)
timeFrame: 6 months
Secondary outcomes:
measure: Assessment of hypoalbuminemia
timeFrame: 6 month
measure: De- and undernutrition
timeFrame: 6 month
measure: Compliance to the treatment
timeFrame: 6 months
measure: complete response rate
timeFrame: 6 months
measure: Assessment of hospitalizations treatment-related complications
timeFrame: 6 months
Other outcomes:
Locations:
city: Le Mans
country: France
facility: Clinique Victor Hugo / Centre Jean Bernard
Study officials:
affiliation: Weprom
name: LE DU Katell, MD
role: STUDY_DIRECTOR
References: