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Impact of Low Muscle Mass in HNC Treated With Immunotherapy (IMMUNONUTRI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04721184
Recruitment Status : Recruiting
First Posted : January 22, 2021
Last Update Posted : January 22, 2021
Sponsor:
Collaborator:
Department of Health, Generalitat de Catalunya
Information provided by (Responsible Party):
Institut Català d'Oncologia

Study Description
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Brief 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)

Condition or disease
Head and Neck Small Cell Carcinoma Sarcopenia

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
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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. - 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

  2. 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

  3. 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

  4. Evaluate changes in body composition [ Time Frame: 2-3 months and 6 months ]
    Assessed by CT scan at L3 level

  5. 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

  6. 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


Eligibility Criteria
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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
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.
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

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


Contacts
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Contact: Lorena Arribas 932607751 larribas@iconcologia.net

Locations
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Spain
Institut Catala d'Oncologia Recruiting
L'Hospitalet De Llobregat, Barcelona, Spain, 08908
Contact: Lorena Arribas    932607751    larribas@iconcologia.net   
Sponsors and Collaborators
Institut Català d'Oncologia
Department of Health, Generalitat de Catalunya
Investigators
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Principal Investigator: Lorena Arribas Institut Catlà d'Oncologia
More Information
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Responsible Party: Institut Català d'Oncologia
ClinicalTrials.gov Identifier: NCT04721184    
Other Study ID Numbers: PR299/20
First Posted: January 22, 2021    Key Record Dates
Last Update Posted: January 22, 2021
Last Verified: January 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Institut Català d'Oncologia:
head and neck cancer
immune checkpoint inhibitors
muscle mass
sarcopenia
Additional relevant MeSH terms:
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Carcinoma
Carcinoma, Small Cell
Small Cell Lung Carcinoma
Sarcopenia
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Muscular Atrophy
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
 Atrophy
Pathological Conditions, Anatomical
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Lung Diseases
Respiratory Tract Diseases