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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| study population | Patient diagnosed with head & neck carcinoma at diagnosis |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| sarcopenia assessment | Other | evaluation of sarcopenia by CT san at the C3 vertebrae |
|
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of the prevalence of sarcopenia by cervical CT scan (C3) | Number of patients with sarcopenia at diagnosis and during treatments | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Assessment of hypoalbuminemia | Number of patients presenting an hypoalbuminemia. | 6 month |
| De- and undernutrition | Number of patients with a BMI <18 and with a prescription for nutritional complements. |
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Inclusion Criteria:
Exclusion Criteria:
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Adult patient diagnosed with head & neck carcinoma non operable and treated by radiotherapy and/or chemotherapy and/or targeted therapy.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magali BALAVOINE | Contact | 241682940 | 0033 | m.balavoine@weprom.fr |
| Jonas DUBU | Contact | jonas.dubu@i-l-c.fr |
| Name | Affiliation | Role |
|---|---|---|
| LE DU Katell, MD | Weprom | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique Victor Hugo / Centre Jean Bernard | Recruiting | Le Mans | 72000 | France |
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| ID | Term |
|---|---|
| D055948 | Sarcopenia |
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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| 6 month |
| Compliance to the treatment | Number of patients having the complete planned treatment | 6 months |
| 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 |
| Assessment of hospitalizations treatment-related complications | Number of hospitalizations per patient for treatment-related complications | 6 months |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |