Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Cancer (SARVADS 1)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Sarcopenia; Cancer of Head and Neck; CT Scan
• Intervention / Treatment: Other: sarcopenia assessment

• Study Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

• Study Contact: Name: Magali BALAVOINE; Phone Number: 0033 241682940; Email: m.balavoine@weprom.fr
• Study Contact Backup: Name: Jonas DUBU; Email: jonas.dubu@i-l-c.fr

Study Locations

• France
  • Le Mans, France, 72000
    • Recruiting
    • Clinique Victor Hugo / Centre Jean Bernard
    • Contact: Jonas DUBU; Phone Number: +33 769510938; Email: jonas.dubu@i-l-c.fr
    • Principal Investigator: Katell Le Dû, MD
    • Principal Investigator: Amandine RUFFIER, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
study population; Patient diagnosed with head & neck carcinoma at diagnosis	Other: sarcopenia assessment; evaluation of sarcopenia by CT san at the C3 vertebrae

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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.	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

Collaborators and Investigators

• Sponsor: Weprom
• Investigators: Study Director: LE DU Katell, MD, Weprom

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2020
• Primary Completion (Anticipated): May 30, 2022
• Study Completion (Anticipated): May 30, 2022

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 16, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Actual): October 8, 2021
• Last Update Submitted That Met QC Criteria: October 7, 2021
• Last Verified: March 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms; Neoplasms by Site; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Head and Neck Neoplasms; Sarcopenia
• Other Study ID Numbers: WP-2020-04

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No