Head and Neck Cancer Clinical Trial
— EDHITOOfficial title:
Randomized Controlled Trial Evaluating the Impact of Therapeutic Patient Education on the Toxicity of Immune Checkpoint Inhibitors in Oncology
Verified date | August 2023 |
Source | Institut Cancerologie de l'Ouest |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this therapeutic education program is to reduce the apparition of immune-related Adverse Event with patients treated with ICI
Status | Active, not recruiting |
Enrollment | 411 |
Est. completion date | February 2024 |
Est. primary completion date | August 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - Patient with Melanoma, Non-Small Cell Bronchial Cancer, renal cell carcinoma, Ca carcinomas of the upper airways to be treated with ICI - Patient who has never received treatment by ICI - Informed patient who signed his consent - Age > or = 18 years - Social insurance Exclusion Criteria: - Patient receiving corticosteroid or immunosuppressant 14 days before inclusion - Immunocompromised patient - Uncontrolled brain metastases - Refusal to participate, patient protected by guardianship - Patient unable to understand the study or unable to follow the education sessions |
Country | Name | City | State |
---|---|---|---|
France | Chu Angers | Angers | |
France | Institut de Cancerologie de L'Ouest | Angers | |
France | Centre Francois Baclesse | Caen | |
France | Centre D'Oncologie Et de Radiotherapie 37 | Chambray-lès-Tours | |
France | Chd Vendee | La Roche-sur-Yon | |
France | Centre Oscar Lambret | Lille | |
France | Centre Leon Berard | Lyon | |
France | Institut Curie | Paris | |
France | Institut de Cancerologie de Lorraine | Vandœuvre-lès-Nancy |
Lead Sponsor | Collaborator |
---|---|
Institut Cancerologie de l'Ouest |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Comparison of the number of patients with at least one grade = 3 immune-related Adverse Event (irAE) toxicity for 25 weeks after initiation of ICI treatment between both arm | Measure of the number of patients with at least one immune-related Adverse Event (irAE) grade = 3 (CTCAE v5.0) for 25 weeks following the beginning of ICI treatment. | 36 months | |
Secondary | Characterize the toxicity of Immune Checkpoint Inhibitors (ICI) | Description of immune-related Adverse Event of grade> 2 | 36 months | |
Secondary | Quantification of ICI treatment received | Description of each cycle of ICI | 36 months | |
Secondary | Measuring the level of knowledge of patients related to the disease, the treatment and its side effects | Measuring the level of knowledge of patients with a specific questionnaire | 36 months | |
Secondary | Patients' quality of life assessment: Hospital Anxiety and Depression Scale | quality of life evaluated with the Hospital Anxiety and Depression Scale | 36 months | |
Secondary | Patients' quality of life assessment: questionnaire-C30 | quality of life evaluated with the Quality-of-life questionnaire-C30 | 36 months |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT05808920 -
The RESCUE Study: Survival and Functional Outcomes Following Salvage Surgery for RESidual or reCurrent sqUamous cEll Carcinoma of the Head and Neck
|
||
Completed |
NCT02526017 -
Study of Cabiralizumab in Combination With Nivolumab in Patients With Selected Advanced Cancers
|
Phase 1 | |
Active, not recruiting |
NCT05060432 -
Study of EOS-448 With Standard of Care and/or Investigational Therapies in Participants With Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT03997643 -
Preservation of Swallowing in Respected Oral Cavity Squamous Cell Carcinoma: Examining Radiation Volume Effects (PRESERVE): A Randomized Trial
|
Phase 2 | |
Active, not recruiting |
NCT03170960 -
Study of Cabozantinib in Combination With Atezolizumab to Subjects With Locally Advanced or Metastatic Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT04700475 -
Effect of Low Level Laser Therapy on Prevention of Radiotherapy Induced Xerostomia in Cancer Patients.
|
N/A | |
Withdrawn |
NCT04058145 -
AMD3100 Plus Pembrolizumab in Immune Checkpoint Blockade Refractory Head and Neck Squamous Cell Carcinoma
|
Phase 2 | |
Completed |
NCT02572869 -
Functional and Aesthetic Outcomes After Mandible Reconstruction With Fibula Osteomyocutaneous Free Flaps
|
||
Active, not recruiting |
NCT04474470 -
A Study to Evaluate NT219 Alone and in Combination With ERBITUX® (Cetuximab) in Adults With Advanced Solid Tumors and Head and Neck Cancer
|
Phase 1/Phase 2 | |
Withdrawn |
NCT05073809 -
Photoacoustic Imaging of Head and Neck Tumours
|
||
Active, not recruiting |
NCT04383210 -
Study of Seribantumab in Adult Patients With NRG1 Gene Fusion Positive Advanced Solid Tumors
|
Phase 2 | |
Active, not recruiting |
NCT03651570 -
Randomized Controlled Trial of a E-intervention to Help Patients Newly Diagnosed With Cancer Cope Better: Pilot Study
|
N/A | |
Recruiting |
NCT04930432 -
Study of MCLA-129, a Human Bispecific EGFR and cMet Antibody, in Patients With Advanced NSCLC and Other Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06016699 -
Immunological Function After Radiation With Either Proton or Photon Therapy
|
||
Terminated |
NCT03843554 -
Commensal Oral Microbiota in Head and Neck Cancer
|
N/A | |
Recruiting |
NCT05915572 -
Mulligan Technique on Shoulder Dysfunction
|
N/A | |
Completed |
NCT05897983 -
Tens and Rocabado Exercises on TMJ Dysfunction
|
N/A | |
Not yet recruiting |
NCT06289049 -
Heavy Strength Training in Head and Neck Cancer Survivors
|
Phase 2 | |
Withdrawn |
NCT05263648 -
Virtual Reality Software to Reduce Stress in Cancer Patients
|
N/A | |
Withdrawn |
NCT03238638 -
A Study of Epacadostat + Pembrolizumab in Head and Neck Cancer Patients, Who Failed Prior PD-1/PD-L1 Therapy
|
Phase 2 |