Study on Skin Toxicities Induced by Cancer Treatments

NCT ID: NCT04402606

Last Updated: 2024-04-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 292 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-11-25
• Study Completion Date: 2024-04-15

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.

Conditions

Solid Tumor, Adult; Breast Cancer; Lung Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Evaluation on skin toxicities

This evaluation consists on a clinical examination of the skin and the realization of the cutaneous measurements of reference on 4 sites frequently exposed to the cutaneous toxicities: face, neckline, palms of the hands and soles of the feet.

Group Type: EXPERIMENTAL

Evaluation on skin toxicities

Intervention Type: OTHER

Measurements will be carried out using specific tools, such as the cutaneous ultrasound system (measurement of the skin layers thicknesses, the cutometer (measurement of the elasticity of the skin), the corneometer (measurement of the hydration of the skin), the pH meter (measuring the pH of the skin), the colorimeter (measuring the color of the skin), the tewameter (measuring the insensible loss of water), the sebometer (measuring sebum).

Interventions

Evaluation on skin toxicities

Measurements will be carried out using specific tools, such as the cutaneous ultrasound system (measurement of the skin layers thicknesses, the cutometer (measurement of the elasticity of the skin), the corneometer (measurement of the hydration of the skin), the pH meter (measuring the pH of the skin), the colorimeter (measuring the color of the skin), the tewameter (measuring the insensible loss of water), the sebometer (measuring sebum).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Institut Curie

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Institut Curie

Paris, , France

Countries

France

Other Identifiers

2019-A0872-55

Identifier Type: -

Identifier Source: org_study_id