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Clinical Trials/NCT04402606
NCT04402606CompletedNot Applicable

DERMACLIC : Study on Skin Toxicities Induced by Cancer Treatments

Institut Curie2 sites in 1 country292 target enrollmentStarted: November 25, 2020Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
292
Locations
2
Primary Endpoint
Estimate the rates of severe skin toxicities (grade 2) induced by cancer treatments, at 8 months after the start of treatment.
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

Brief Summary

The skin toxicities will be evaluated on patient (male or female) with an indication of cancer treatment in the case of solid tumor of the breast, or lung.

Study Design

Study Type
Interventional
Allocation
Na
Intervention Model
Single Group
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Patient, male or female, aged 18 years and older, with a solid tumor breast or lung, localized, locally advanced or not, metastatic or not;
  • •Patient in medical oncology consultation requiring systemic anti-tumor therapy (chemotherapy, targeted therapy, hormone therapy, immunotherapy) in neo-adjuvant, adjuvant or metastatic;
  • •Treatment planned for a minimum period of 3 months (from the date of inclusion);
  • •Having a social security protection;
  • •Signed informed consent form of the study.

Exclusion Criteria

  • •Patient treated for lymphoma, leukemia or inflammatory breast cancer ;
  • •Patient with a solid tumour which location is other than breast or lung;
  • •Patient with a tumor wound ;
  • •Patient with a general condition > 2 at baseline (ECOG classification) ;
  • •Patient receiving anti-tumor treatment with radiotherapy exclusively or associated with concomitant radiotherapy ;
  • •Patient unable to receive information about the study and to give consent ;
  • •Persons deprived of liberty or guardianship ;
  • •Impossible submission to study procedures for geographical or psychological reasons.

Outcomes

Primary Outcomes

Estimate the rates of severe skin toxicities (grade 2) induced by cancer treatments, at 8 months after the start of treatment.

Time Frame: 8 months

Severity of cutaneous toxicities at 8 months after the start of treatment (grade \> 2 according to the NCI-CTCAE classification version 4.03), induced by the anticancer treatments.

Secondary Outcomes

  • Define patient profiles likely to develop severe cutaneous toxicity during their anticancer treatment;(8 months)
  • Evaluate variation rate of skin hydration over the course of the study(8 months)
  • Evaluate the thickness, firmness, tone, viscosity of the skin in case of skin toxicities(8 months)
  • Evaluate variation rate of thickness, firmness, tone, viscosity of the skin over the course of the study(8 months)
  • Evaluate variation rate of skin color over the course of the study(8 months)
  • Evaluate variation rate of skin sebum quantity over the course of the study(8 months)
  • Evaluate the temperature in case of skin toxicities(8 months)
  • Evaluate skin elasticity index in case of toxicities(8 months)
  • Evaluate variation rate of skin pH over the course of the study(8 months)
  • Evaluate variation rate of skin temperature over the course of the study(8 months)
  • Evaluate variation rate of insensitive loss of water of the skin over the course of the study(8 months)
  • Evaluate skin color in case of skin toxicities(8 months)
  • Evaluate the quantity of sebum in case of toxicities(8 months)
  • Evaluate variation rate of skin elasticity over the course of the study(8 months)
  • Evaluate plantar supports in case of toxicities(8 months)
  • Evaluate Skin hydration rate in case of skin toxicities(8 months)
  • Evaluate variation rate of plantar supports over the course of the study(8 months)
  • To evaluate the quality of life of patients at 8 months;(8 months)
  • Evaluate the skin pH in case of skin toxicities(8 months)
  • Evaluate insensitive loss of water in case of toxicities(8 months)
  • Evaluate the consequences of cutaneous toxicities on the patient's therapeutic scheme (hold, dosage reduction, change of molecule);(8 months)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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