Clinical trial NCT04402606: Study on Skin Toxicities Induced by Cancer Treatments
Official title: DERMACLIC : Study on Skin Toxicities Induced by Cancer Treatments
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Solid Tumor, Adult
Breast Cancer
Lung Cancer
Lead sponsor: Institut Curie
Sponsor class: OTHER
First posted: 2020-05-27
Enrollment: 292
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Estimate the rates of severe skin toxicities (grade 2) induced by cancer treatments, at 8 months after the start of treatment.
timeFrame: 8 months
Secondary outcomes:
measure: Evaluate the thickness, firmness, tone, viscosity of the skin in case of skin toxicities
timeFrame: 8 months
measure: Evaluate skin color in case of skin toxicities
timeFrame: 8 months
measure: Evaluate the skin pH in case of skin toxicities
timeFrame: 8 months
measure: Evaluate the temperature in case of skin toxicities
timeFrame: 8 months
measure: Evaluate the quantity of sebum in case of toxicities
timeFrame: 8 months
measure: Evaluate plantar supports in case of toxicities
timeFrame: 8 months
measure: Evaluate Skin hydration rate in case of skin toxicities
timeFrame: 8 months
measure: Evaluate skin elasticity index in case of toxicities
timeFrame: 8 months
measure: Evaluate insensitive loss of water in case of toxicities
timeFrame: 8 months
measure: Evaluate variation rate of thickness, firmness, tone, viscosity of the skin over the course of the study
timeFrame: 8 months
measure: Evaluate variation rate of skin color over the course of the study
timeFrame: 8 months
measure: Evaluate variation rate of skin pH over the course of the study
timeFrame: 8 months
measure: Evaluate variation rate of skin temperature over the course of the study
timeFrame: 8 months
measure: Evaluate variation rate of skin sebum quantity over the course of the study
timeFrame: 8 months
measure: Evaluate variation rate of plantar supports over the course of the study
timeFrame: 8 months
measure: Evaluate variation rate of skin hydration over the course of the study
timeFrame: 8 months
measure: Evaluate variation rate of skin elasticity over the course of the study
timeFrame: 8 months
measure: Evaluate variation rate of insensitive loss of water of the skin over the course of the study
timeFrame: 8 months
measure: Evaluate the consequences of cutaneous toxicities on the patient's therapeutic scheme (hold, dosage reduction, change of molecule);
timeFrame: 8 months
measure: To evaluate the quality of life of patients at 8 months;
timeFrame: 8 months
measure: Define patient profiles likely to develop severe cutaneous toxicity during their anticancer treatment;
timeFrame: 8 months
Other outcomes:
Locations:
city: Paris
country: France
facility: Institut Curie
Study officials:
References: