Status:
COMPLETED
Satisfaction and Quality of Life Comparison Between Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGFR)
Lead Sponsor:
Centre Leon Berard
Conditions:
Head and Neck Squamous Cell Carcinoma
Colorectal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squa...
Detailed Description
The arrival of new therapeutic strategies such as targeted therapies has led to real progress in the treatment of cancers. Tyrosine kinase inhibitors and antibodies to epidermal growth factor receptor...
Eligibility Criteria
Inclusion
- Age ≥ 18 years.
- Patient with recurrent and / or metastatic head and neck squamous cell carcinoma OR metastatic colorectal cancer with non-mutated RAS gene (wild-type) OR non-small cell lung cancer (NSCLC) with EGFR activating mutations.
- Treated for the first time by an iEGFR having received a marketing authorization.
- Having signed a consent to participate in the study.
- Affiliated to a health insurance plan (or beneficiary of such a plan).
Exclusion
- Concomitant radiotherapy.
- Unresolved skin toxicity from previous treatment, whatever it may be.
- Concomitant use of other topical treatments.
- Known hypersensitivity to at least one of the components of the topicals used.
- Pregnant or lactating women.
- Participation in another clinical trial (even if supportive care)
Key Trial Info
Start Date :
February 16 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 11 2021
Estimated Enrollment :
102 Patients enrolled
Trial Details
Trial ID
NCT03421912
Start Date
February 16 2018
End Date
May 11 2021
Last Update
July 9 2021
Active Locations (1)
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1
Centre Léon Bérard
Lyon, Rhône, France, 69008