Study on Skin Toxicities Induced by Cancer Treatments

NCT04402606 | Completed

• 1 other identifier: 2019-A0872-55
• Study Type: interventional
• Target: 292
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

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

  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.

  8 months

Secondary Outcomes (21)

• Evaluate the thickness, firmness, tone, viscosity of the skin in case of skin toxicities

  8 months

• Evaluate skin color in case of skin toxicities

  8 months

• Evaluate the skin pH in case of skin toxicities

  8 months

• Evaluate the temperature in case of skin toxicities

  8 months

• Evaluate the quantity of sebum in case of toxicities

  8 months

Study Arms (1)

Evaluation on skin toxicities

EXPERIMENTAL

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.

Other: Evaluation on skin toxicities

Interventions

Evaluation on skin toxicities 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).

Evaluation on skin toxicities

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• Having a social security protection;
• Signed informed consent form of the study.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Institut Curie: lead

Study Sites (1)

Institut Curie

Paris, 75, France

Location

MeSH Terms

Conditions

Breast Neoplasms; Lung Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2020
• First Posted: May 27, 2020
• Study Start: November 25, 2020
• Primary Completion: November 25, 2020
• Study Completion: April 15, 2024
• Last Updated: April 18, 2024

Record last verified: 2024-04

Locations

FR (1)