Satisfaction and Quality of Life Comparison Between Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGFR) (CICAFIX)

Comparative Monocentric Randomized Study Evaluating the Satisfaction and Quality of Life of Patients Using Cicaplast Baume B5 Versus Dexeryl for the Management of Cutaneous Toxicities Induced by Epidermal Growth Factor Receptor Inhibitors (iEGRF) in Carcinomas Squamous Cells of the Head and Neck, Colorectal Cancers or Lung Cancers

This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary

Study Overview

• Status: Completed
• Conditions: Colorectal Cancer; Non Small Cell Lung Cancer; Head and Neck Squamous Cell Carcinoma; Epidermal Growth Factor Receptor Inhibitor
• Intervention / Treatment: Other: Cicaplast Balm B5; Other: Dexeryl

Detailed Description

The arrival of new therapeutic strategies such as targeted therapies has led to real progress in the treatment of cancers. Tyrosine kinase inhibitors and antibodies to epidermal growth factor receptors (EGFR), or iEGFR, target one of the major pathways of tumor cell proliferation. These treatments have demonstrated their interest in the treatment of certain advanced solid malignant tumors (head and neck cancer, colorectal cancer, bronchial cancer).

Although having a much better tolerance profile than the "classical" cytotoxic treatments used in the same indications, these treatments, however, have frequent cutaneous toxicities that are inconvenient for patients. According to the molecules, they can affect 80 to 90% of patients treated from the first weeks of treatment and to different degrees. They appear as well in the skin (acneiform rash, erythema, desquamation, xerosis, pruritus) as skin appendages (paronychia, alopecia).

The consequences of these adverse effects are significant, which may be at the origin of a decrease in dose or even of a stop of anti-tumoral treatment inducing a reduction of the expected clinical benefit. In addition, they represent for the patient a real source of inconvenience and pain, which can impact the quality of life (choice of dress, feeling of shame because of the appearance of the skin ...) and impact the adherence to iEGFR treatment.

Management includes first and foremost preventive measures: the use of moisturizing topicals and dermatological soap-free surgras is recommended as soon as iEGFR treatment is initiated, and preventive systemic treatment with cyclins (doxycycline 100 mg daily) is proposed for at least 6 weeks and then reevaluated for skin toxicity.

In case of appearance of skin toxicities, it is initially prescribed in common practice a topical such as Dexeryl (used in many hospitals as standard) or Cicaplast Balm B5 La Roche Posay (used in current practice at Léon Bérard Center). In a second step, topical corticosteroids are prescribed, depending on the grade of toxicity.

There is, however, no validated argument in the literature to guide the choice of clinicians to use either of these topics. Cicaplast balm B5 (antibacterial, repairing damaged skin, moisturizing and relieving feelings of discomfort) would limit the aggravation of skin toxicities and therefore the use of pharmacological measures, including topical corticosteroids class 3 or 4 may long term, weaken the skin barrier even more.

This randomized comparative study aims to evaluate the satisfaction and quality of life of patients using Cicaplast balm B5, versus Dexeryl, for the management of cutaneous toxicities of iEGFR in squamous cell carcinoma of the head and neck, cancers colorectal or pulmonary

• Study Type: Interventional
• Enrollment (Actual): 102
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhône
    • Lyon, Rhône, France, 69008
      • Centre Léon Bérard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Patient with recurrent and / or metastatic head and neck squamous cell carcinoma OR metastatic colorectal cancer with non-mutated RAS gene (wild-type) OR non-small cell lung cancer (NSCLC) with EGFR activating mutations.
• Treated for the first time by an iEGFR having received a marketing authorization.
• Having signed a consent to participate in the study.
• Affiliated to a health insurance plan (or beneficiary of such a plan).

Exclusion Criteria:

• Concomitant radiotherapy.
• Unresolved skin toxicity from previous treatment, whatever it may be.
• Concomitant use of other topical treatments.
• Known hypersensitivity to at least one of the components of the topicals used.
• Pregnant or lactating women.
• Participation in another clinical trial (even if supportive care)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A : Cicaplast balm B5; Use of Cicaplast balm B5, 2 to 3 applications per day, since the first day of iEGFR treatment initiation for 30 days to avoid or limit appearance of cutaneous toxicities related to iEGFR treatment.	Other: Cicaplast Balm B5; The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers
Active Comparator: Arm B : Dexeryl; Use of Dexeryl, 2 to 3 applications per day, since de first day of iEGFR treatment initiation for 30 days to avoid or limit appearence of cutaneous toxicities related to iEGFR treatment.	Other: Dexeryl; The patients have to do 2 to 3 applications per day on the face, on lesions and in poultice in the evening in case of painful crack on the fingers

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall patient satisfaction after 30 days treatment	Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm	After 30 days of treatment or at the end of treatment for patient who interrupt the treatment before 30 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall patient satisfaction after 60 days treatment	Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm	After 60 days of treatment or at the end of treatment for patient who interrupt the treatment before 60 days
Patient Quality of life	Quality of life of patient will be evaluated by using the Dermatology Life Quality Index questionnaire (DLQI) in each arm	At inclusion, after 30 and 60 days of treatment
Cutaneous toxicities evaluation using Epidermal Repair Score (SCOREPI)	Cutaneous toxicities will be evaluated in each arm by using Epidermal Repair Score (SCOREPI)	After 15, 30 and 60 days of treatment
Cutaneous toxicities evaluation using Common Terminology Criteria for Adverse Events (CTCAE) version 4	Cutaneous toxicities will be evaluated in each arm by using Common Terminology Criteria for Adverse Events (CTCAE) version 4	After 15, 30 and 60 days of treatment
Modification/Interruption/Discontinuing iEGFR treatment rate	Modification/Interruption/Discontinuing iEGFR treatment rate in each arm because of cutaneous toxicity	Continuously up to 30 days after starting treatment
DLQI and SCOREPI scores correlation	Evaluation of DLQI (patient evaluation) and SCOREPI (investigator evaluation) scores correlation in each arm	After 30 and 60 days of treatment
Topical observance	Topical observance will be evaluated in each arm by data collection by each patient in a diary	Between the 1st day and the 15th day of treatment, and between the 15th and the 30th day of treatment
Use rate of dermocorticoids	Evaluation of the rate of patients needing to use dermocorticoids.	Continously up to 60 days after starting treatment

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Jérôme FAYETTE, Doctor, Centre Léon Bérard, Lyon, France

Study record dates

Study Major Dates

• Study Start (Actual): February 16, 2018
• Primary Completion (Actual): April 11, 2021
• Study Completion (Actual): May 11, 2021

Study Registration Dates

• First Submitted: January 29, 2018
• First Submitted That Met QC Criteria: February 2, 2018
• First Posted (Actual): February 5, 2018

Study Record Updates

• Last Update Posted (Actual): July 9, 2021
• Last Update Submitted That Met QC Criteria: July 8, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Patient satisfaction; Quality of life; Topical treatment; Prevention strategy; Cutaneous toxicity; Dermatology Life Quality Index (DLQI); Epidermal Repair Score (SCOREPI)
• Additional Relevant MeSH Terms: Digestive System Diseases; Respiratory Tract Diseases; Neoplasms by Histologic Type; Neoplasms; Lung Diseases; Neoplasms by Site; Neoplasms, Glandular and Epithelial; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Head and Neck Neoplasms; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Carcinoma, Squamous Cell; Lung Neoplasms; Carcinoma; Colorectal Neoplasms; Squamous Cell Carcinoma of Head and Neck
• Other Study ID Numbers: CICAFIX - ET17-011

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No