SarcopeniaSARVADS 1NCT04804852
Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Cancer
An observational study of Sarcopenia and Cancer of Head and Neck, run by Weprom at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sarcopenia, Cancer of Head and Neck, CT Scan
- What is being tested?
- sarcopenia assessment
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- 29 Oct 2020to 30 May 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patient diagnosed with head \& neck carcinoma non operable and treated by radiotherapy and/or chemotherapy and/or targeted therapy.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Jonas DUBU contact
France1 site, 1 recruiting
- Recruiting
Clinique Victor Hugo / Centre Jean Bernard
Le Mans, 72000
Jonas DUBU, +33 769510938, jonas.dubu@i-l-c.fr
Katell LE DÛ, MD
About this study
Official title: 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).
Read more
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.
- Conditions
- Sarcopenia, Cancer of Head and Neck, CT Scan
- Being tested
- sarcopenia assessment
- Medical subject headings
- Sarcopenia, Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sarcopenia assessmentOther
evaluation of sarcopenia by CT san at the C3 vertebrae
| Study group | Role | What they receive |
|---|---|---|
| study population | Patient diagnosed with head \& neck carcinoma at diagnosis Receives: Other: sarcopenia assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the prevalence of sarcopenia by cervical CT scan (C3)
Number of patients with sarcopenia at diagnosis and during treatments
Measured: 6 months
Secondary outcomes (5)
Assessment of hypoalbuminemia
Number of patients presenting an hypoalbuminemia.
Measured: 6 month
De- and undernutrition
Number of patients with a BMI <18 and with a prescription for nutritional complements.
Measured: 6 month
Compliance to the treatment
Number of patients having the complete planned treatment
Measured: 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
Measured: 6 months
Assessment of hospitalizations treatment-related complications
Number of hospitalizations per patient for treatment-related complications
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study start29 Oct 2020
- Primary completion30 May 2022 (estimated)
- Study completion30 May 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Weprom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LE DU Katell, MD, Study director, Weprom
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04804852
- Sponsor's protocol ID
- WP-2020-04
- Acronym
- SARVADS 1
- Status last verified
- Mar 2021
- First submitted
- 16 Mar 2021
- Last updated
- 8 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Prevalence of Sarcopenia by CT Scan in Patients Diagnosed With Head & Neck Carcinoma
- ClinicalTrials.gov ID
- NCT04804852
- Acronym / sponsor ID
- SARVADS 1 / WP-2020-04
- Conditions
- Sarcopenia, Cancer of Head and Neck, CT Scan
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- WepromUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 30 May 2022 (estimated)
- Study completion
- 30 May 2022 (estimated)
- First posted
- 18 Mar 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| study population | – | Other: sarcopenia assessmentPatient diagnosed with head \& neck carcinoma at diagnosis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patient diagnosed with head \& neck carcinoma non operable and treated by radiotherapy and/or chemotherapy and/or targeted therapy.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| sarcopenia assessmentevaluation of sarcopenia by CT san at the C3 vertebrae | Other | study population |
Primary outcome
Assessment of the prevalence of sarcopenia by cervical CT scan (C3)
Time frame: 6 months
Number of patients with sarcopenia at diagnosis and during treatments
5 secondary outcomes
Assessment of hypoalbuminemia
Time frame: 6 month
De- and undernutrition
Time frame: 6 month
Compliance to the treatment
Time frame: 6 months
complete response rate
Time frame: 6 months
Assessment of hospitalizations treatment-related complications
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jonas DUBU contact
LE DU Katell, MD study director
Weprom
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sarcopenia and Cancer of Head and Neck, run by Weprom at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Magali BALAVOINE (241682940 ext. 0033, m.balavoine@weprom.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of the prevalence of sarcopenia by cervical CT scan (C3) (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Oct 2021.