Impact of Low Muscle Mass in HNC Treated With Immunotherapy (IMMUNONUTRI)
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|ClinicalTrials.gov Identifier: NCT04721184|
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
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|Condition or disease|
|Head and Neck Small Cell Carcinoma Sarcopenia|
|Study Type :||Observational|
|Estimated Enrollment :||120 participants|
|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)|
|Actual Study Start Date :||January 20, 2021|
|Estimated Primary Completion Date :||November 2023|
|Estimated Study Completion Date :||August 2024|
- 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
- - 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 ]Evaluated by full nutritional assessment
- Evaluate baseline muscle mass as a predictive biomarker of toxicity [ Time Frame: 2-3 months and 6 months ]Assessed by CT scan at L3 level
- Evaluate the impact of adipose tissue as a predictor of survival and toxicity [ Time Frame: 6 months ]Assessed by CT scan at L3 level including total adipose tissue, subcutaneous, visceral and intramuscular fat mass
- Evaluate changes in body composition [ Time Frame: 2-3 months and 6 months ]Assessed by CT scan at L3 level
- Evaluate the need for nutritional support throughout the treatment and the type if so [ Time Frame: through study completion, on average of 6 months ]Evaluated after performed full nutritional assessment by a checklist with all different options
- 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 ]Assessed by CT scan at L3 level and blood sample
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
|Sampling Method:||Non-Probability Sample|
- 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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04721184
|Contact: Lorena Arribasemail@example.com|
|Institut Catala d'Oncologia||Recruiting|
|L'Hospitalet De Llobregat, Barcelona, Spain, 08908|
|Contact: Lorena Arribas 932607751 firstname.lastname@example.org|
|Principal Investigator:||Lorena Arribas||Institut Catlà d'Oncologia|
|Responsible Party:||Institut Català d'Oncologia|
|Other Study ID Numbers:||
|First Posted:||January 22, 2021 Key Record Dates|
|Last Update Posted:||January 22, 2021|
|Last Verified:||January 2021|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
head and neck cancer
immune checkpoint inhibitors
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Nervous System Diseases
Pathological Conditions, Anatomical
Respiratory Tract Neoplasms
Neoplasms by Site
Respiratory Tract Diseases