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Study on Skin Toxicities Induced by Cancer Treatments (DERMACLIC)

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ClinicalTrials.gov Identifier: NCT04402606
Recruitment Status : Recruiting
First Posted : May 27, 2020
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Institut Curie

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, lung, digestive system or ENT (Ear, nose and throat).

Condition or disease Intervention/treatment Phase
Solid Tumor, Adult Breast Cancer Lung Cancer Digestive System Cancer Ear Cancer Nose Cancer Throat Cancer Other: Evaluation on skin toxicities Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: DERMACLIC : Study on Skin Toxicities Induced by Cancer Treatments
Actual Study Start Date : November 25, 2020
Actual Primary Completion Date : April 12, 2021
Estimated Study Completion Date : July 1, 2023

Arm Intervention/treatment
Experimental: 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.
Other: 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).




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Evaluate the thickness, firmness, tone, viscosity of the skin in case of skin toxicities [ Time Frame: 8 months ]
    The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. A cutaneous ultrasound system will be used to evaluate thickness of the skin and a cutometer will be used to evaluate firmness, tone and viscosity of the skin. The measurement in millimeters will be used to assess this outcome measure.

  2. Evaluate skin color in case of skin toxicities [ Time Frame: 8 months ]
    The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. A colorimeter will be used to evaluate skin color. No unit will be used to assess this outcome measure.

  3. Evaluate the skin pH in case of skin toxicities [ Time Frame: 8 months ]
    The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. A pHmeter will be used to evaluate skin pH. No unit will be used to assess this outcome measure

  4. Evaluate the temperature in case of skin toxicities [ Time Frame: 8 months ]
    The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Thermometer will be used to evaluate temperature of the skin. The measurement in degrees Celsius will be used to assess this outcome measure.

  5. Evaluate the quantity of sebum in case of toxicities [ Time Frame: 8 months ]
    The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Sebumeter will be used to evaluate quantity of sebum of the skin. The measurement in microgram/centimeter^2 will be used to assess this outcome measure

  6. Evaluate plantar supports in case of toxicities [ Time Frame: 8 months ]
    The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Podobarometric platform will be used to evaluate plantar supports. The measurement in N/Centimeter^2 will be used to assess this outcome measure.

  7. Evaluate Skin hydration rate in case of skin toxicities [ Time Frame: 8 months ]
    The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Corneometer will be used to evaluate skin hydration rate. No unit will be used to assess this outcome measure.

  8. Evaluate skin elasticity index in case of toxicities [ Time Frame: 8 months ]
    The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Cutometer will be used to evaluate skin elasticy. No unit will be used to assess this outcome measure.

  9. Evaluate insensitive loss of water in case of toxicities [ Time Frame: 8 months ]
    The assessments will be performed at day 0 (before the start of the study) and at 1 month (M1), M2, M3, M4 and M8 after the start of treatment. Tewameter will be used to evaluate insensitive loss of water. The measurement in gram/meter^2/hour will be used to assess this outcome measure.

  10. Evaluate variation rate of thickness, firmness, tone, viscosity of the skin over the course of the study [ Time Frame: 8 months ]
    A cutaneous ultrasound system will be used to evaluate thickness of the skin and a cutometer will be used to evaluate firmness, tone and viscosity of the skin. The measurement in millimeters will be used to assess this outcome measure. Variations of thickness, firmness, tone, viscosity of the skin will be calculated according to results obtained at M1, M2,M3, M4 and M8. Results will be compared to initial measures at day 0. Variation rate will be estimated in percentage.

  11. Evaluate variation rate of skin color over the course of the study [ Time Frame: 8 months ]
    A colorimeter will be used to evaluate skin color. No unit will be used to assess this outcome measure. Variations of skin color will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.

  12. Evaluate variation rate of skin pH over the course of the study [ Time Frame: 8 months ]
    A pHmeter will be used to evaluate skin pH. No unit will be used to assess this outcome measure. Variations of pH of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage

  13. Evaluate variation rate of skin temperature over the course of the study [ Time Frame: 8 months ]
    A thermometer will be used to evaluate skin temperature. The measurement in degrees Celsius will be used to assess this outcome measure. Variations of temperature of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.

  14. Evaluate variation rate of skin sebum quantity over the course of the study [ Time Frame: 8 months ]
    A sebumeter will be used to evaluate quantity of sebum of the skin. The measurement in microgram/centimeter^2 will be used to assess this outcome measure. Variations of quantity of sebum of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.

  15. Evaluate variation rate of plantar supports over the course of the study [ Time Frame: 8 months ]
    A podobarometric platform will be used to evaluate plantar supports. The measurement in N/Centimeter^2 will be used to assess this outcome measure. Variations of plantar supports will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.

  16. Evaluate variation rate of skin hydration over the course of the study [ Time Frame: 8 months ]
    A corneometer will be used to evaluate skin hydration rate. No unit will be used to assess this outcome measure. Variations of skin hydration of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.

  17. Evaluate variation rate of skin elasticity over the course of the study [ Time Frame: 8 months ]
    A cutometer will be used to evaluate skin elasticy. No unit will be used to assess this outcome measure. Variations of elasticity of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.

  18. Evaluate variation rate of insensitive loss of water of the skin over the course of the study [ Time Frame: 8 months ]
    A tewameter will be used to evaluate insensitive loss of water. The measurement in gram/meter^2/hour will be used to assess this outcome measure. Variations of insensitive loss of water of the skin will be calculated according to results obtained at M1, M2,M3,M4 and M8. Results will be compared to initial measure at day 0. Variation rate will be estimated in percentage.

  19. Evaluate the consequences of cutaneous toxicities on the patient's therapeutic scheme (hold, dosage reduction, change of molecule); [ Time Frame: 8 months ]
    Number of treatment interruptions or dose changes related to skin toxicities;

  20. To evaluate the quality of life of patients at 8 months; [ Time Frame: 8 months ]
    A questionnaire (Medical Outcome Study Short Form - 36 (MOS SF-36) will be completed by patients. This is a scale allowing to assess health regardless of causal pathology, gender, age and treatment, which is related to patients level of well-being. A score from 0 (poor quality of life) to 100 (very good quality of life) will be given;

  21. Define patient profiles likely to develop severe cutaneous toxicity during their anticancer treatment; [ Time Frame: 8 months ]
    During these assessments, a census of skin toxicities (grade >2) will be carried out according to the NCI-CTCAE version 4.03 classification, and the patient's medical record will be analyzed to determine the predictors of skin toxicities.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patient, male or female, aged 18 years and older, with a solid tumor breast, lung, digestive or ENT type, 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, lung, digestive or ENT;
  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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04402606


Contacts
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Contact: Aurélie THULEAU, Project manager +33 1 44324228 drci.promotion@curie.fr
Contact: Isabelle FROMANTIN, PhD, IDE +33 1 44324428 drci.promotion@curie.fr

Locations
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France
Institut Curie Recruiting
Paris, France, 75
Contact: aurelie thuleau, project manager    +33 1 44324228    drci-promotion@curie.fr   
Principal Investigator: Hedi CHABANOL, Podiatrist         
Sponsors and Collaborators
Institut Curie
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Responsible Party: Institut Curie
ClinicalTrials.gov Identifier: NCT04402606    
Other Study ID Numbers: 2019-A0872-55
First Posted: May 27, 2020    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: April 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases