Head and Neck Small Cell CarcinomaIMMUNONUTRINCT04721184
Impact of Low Muscle Mass in HNC Treated With Immunotherapy
An observational study of Head and Neck Small Cell Carcinoma and Sarcopenia, run by Institut Català d'Oncologia at 1 site in Spain.
Trial summary
The purpose of the study is to evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Small Cell Carcinoma, Sarcopenia
- How many people
- 120 participants
- Where
- 1 siteSpain
- Study dates
- 20 Jan 2021to Aug 2024
- 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: A longitudinal prospective study will be carried out of 120 patients with a diagnosis of recurrence or metastatic SCCHN who start treatment with immunotherapy-based regimens at the Institut Català d'Oncologia- L'Hospitalet from November 2020 until the necessary sample size is completed.
Who may be able to join
- Patients diagnosed with recurrence or metastatic SCCHN treated with antiPDL1, antiPD1 or antiCTLA-4 drugs, alone or in combination within our institution.
- Patients who have previously signed informed consent.
- Patients with measurable tumor lesions.
Who cannot join
- Patients with non-measurable lesions.
- Patients who do not sign the informed consent.
- Patients not treated with immunotherapy.
- Patients in a double-blind trial in whom the assigned branch is not known.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Institut Catala d'Oncologia
L'Hospitalet de Llobregat, Barcelona, 08908
Lorena Arribas, 932607751, larribas@iconcologia.net
About this study
Official title: Impact of Body Composition on the Prognosis and Toxicity of Patients Diagnosed With Recurrence or Metastasic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treated With Immune Checkpoint Inhibitors (ICI)
The purpose of the study is to evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)
Read the detailed description
Body composition including sarcopenia (loss of muscle mass), sarcopenic obesity, and mioesteaosis has been well reported to be an independent predictors of mortality, toxicity, and complications in cancer patients with different locations and treatments. However, there are currently no data on impact of body composition and the oncological outcomes in SCCHN patients treated with immune checkpoint inhibitors (ICI) due to recurrence or metastasic disease.
- Conditions
- Head and Neck Small Cell Carcinoma, Sarcopenia
- Keywords
- head and neck cancer, immune checkpoint inhibitors, muscle mass, sarcopenia
- Medical subject headings
- Sarcopenia, Head and Neck Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)
Assessed by CT scan at L3 level
Measured: at baseline
Secondary outcomes (6)
- To evaluate the impact of malnutrition and weight loss on overall survival, recurrence-free survival, locoregional control, and toxicity in patients with recurrence or metastatic SCCHN treated with immunotherapy-based regimens.
Evaluated by full nutritional assessment
Measured: 2-3 months and 6 months
Evaluate baseline muscle mass as a predictive biomarker of toxicity
Assessed by CT scan at L3 level
Measured: 2-3 months and 6 months
Evaluate the impact of adipose tissue as a predictor of survival and toxicity
Assessed by CT scan at L3 level including total adipose tissue, subcutaneous, visceral and intramuscular fat mass
Measured: 6 months
Evaluate changes in body composition
Assessed by CT scan at L3 level
Measured: 2-3 months and 6 months
Evaluate the need for nutritional support throughout the treatment and the type if so
Evaluated after performed full nutritional assessment by a checklist with all different options
Measured: through study completion, on average of 6 months
Observe the correlation of a lower muscle mass with an increase in inflammatory parameters and oncological outcomes
Assessed by CT scan at L3 level and blood sample
Measured: 2-3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2021
- Study start20 Jan 2021
- Primary completionNov 2023 (estimated)
- Study completionAug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Small Cell CarcinomaStudies 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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Institut Català d'Oncologia
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Responsible party
- Sponsor
- Investigators
- Lorena Arribas, Principal investigator, Institut Catlà d'Oncologia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04721184
- Sponsor's protocol ID
- PR299/20
- Acronym
- IMMUNONUTRI
- Status last verified
- Jan 2021
- First submitted
- 25 Nov 2020
- Last updated
- 22 Jan 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Body Composition on the Prognosis and Toxicity of Patients Diagnosed With Recurrence or Metastasic Squamous Cell Carcinoma of the Head and Neck (SCCHN) Treated With Immune Checkpoint Inhibitors (ICI)
- ClinicalTrials.gov ID
- NCT04721184
- Acronym / sponsor ID
- IMMUNONUTRI / PR299/20
- Conditions
- Head and Neck Small Cell Carcinoma, Sarcopenia
- Keywords
- head and neck cancer, immune checkpoint inhibitors, muscle mass, sarcopenia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Institut Català d'OncologiaUniversity, hospital or other
- Collaborators
- Department of Health, Generalitat de Catalunya
- Study start
- 20 Jan 2021 (actual)
- Primary completion
- Nov 2023 (estimated)
- Study completion
- Aug 2024 (estimated)
- First posted
- 22 Jan 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.
The purpose of the study is to evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)
Detailed description
Body composition including sarcopenia (loss of muscle mass), sarcopenic obesity, and mioesteaosis has been well reported to be an independent predictors of mortality, toxicity, and complications in cancer patients with different locations and treatments. However, there are currently no data on impact of body composition and the oncological outcomes in SCCHN patients treated with immune checkpoint inhibitors (ICI) due to recurrence or metastasic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A longitudinal prospective study will be carried out of 120 patients with a diagnosis of recurrence or metastatic SCCHN who start treatment with immunotherapy-based regimens at the Institut Català d'Oncologia- L'Hospitalet from November 2020 until the necessary sample size is completed.
Key inclusion criteria (3 listed)
- Patients diagnosed with recurrence or metastatic SCCHN treated with antiPDL1, antiPD1 or antiCTLA-4 drugs, alone or in combination within our institution.
- Patients who have previously signed informed consent.
- Patients with measurable tumor lesions.
Key exclusion criteria (4 listed)
- Patients with non-measurable lesions.
- Patients who do not sign the informed consent.
- Patients not treated with immunotherapy.
- Patients in a double-blind trial in whom the assigned branch is not known.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI)
Time frame: at baseline
Assessed by CT scan at L3 level
6 secondary outcomes
- To evaluate the impact of malnutrition and weight loss on overall survival, recurrence-free survival, locoregional control, and toxicity in patients with recurrence or metastatic SCCHN treated with immunotherapy-based regimens.
Time frame: 2-3 months and 6 months
Evaluate baseline muscle mass as a predictive biomarker of toxicity
Time frame: 2-3 months and 6 months
Evaluate the impact of adipose tissue as a predictor of survival and toxicity
Time frame: 6 months
Evaluate changes in body composition
Time frame: 2-3 months and 6 months
Evaluate the need for nutritional support throughout the treatment and the type if so
Time frame: through study completion, on average of 6 months
Observe the correlation of a lower muscle mass with an increase in inflammatory parameters and oncological outcomes
Time frame: 2-3 months and 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2021.
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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.
Lorena Arribas principal investigator
Institut Catlà d'Oncologia
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 Head and Neck Small Cell Carcinoma and Sarcopenia, run by Institut Català d'Oncologia at 1 site in Spain.
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 3 inclusion and 4 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 22 Jan 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 Spain. 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 Lorena Arribas (932607751, larribas@iconcologia.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the baseline muscle mass as a predictive biomarker of treatment response in patients with recurrence or metastatic squamous cell carcinoma of the head and the neck (SCCHN) treated with immune checkpoint inhibitors (ICI) (time frame: at baseline). 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 22 Jan 2021.