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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04804852
Acronym
SARVADS 1
Enrollment
50
Registered
2021-03-18
Start date
2020-10-29
Completion date
2022-05-30
Last updated
2021-10-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer of Head and Neck, CT Scan, Sarcopenia

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.

Interventions

evaluation of sarcopenia by CT san at the C3 vertebrae

Sponsors

Weprom
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Assessment of the prevalence of sarcopenia by cervical CT scan (C3)6 monthsNumber of patients with sarcopenia at diagnosis and during treatments

Secondary

MeasureTime frameDescription
Assessment of hypoalbuminemia6 monthNumber of patients presenting an hypoalbuminemia.
De- and undernutrition6 monthNumber of patients with a BMI \<18 and with a prescription for nutritional complements.
Compliance to the treatment6 monthsNumber of patients having the complete planned treatment
complete response rate6 monthsNumber 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
Assessment of hospitalizations treatment-related complications6 monthsNumber of hospitalizations per patient for treatment-related complications

Countries

France

Contacts

Primary ContactMagali BALAVOINE
m.balavoine@weprom.fr241682940
Backup ContactJonas DUBU
jonas.dubu@i-l-c.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026