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)

NCT03421912 | Completed

• 1 other identifier: CICAFIX - ET17-011
• Study Type: interventional
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Head and Neck Squamous Cell Carcinoma; Colorectal Cancer; Non Small Cell Lung Cancer; Epidermal Growth Factor Receptor Inhibitor

Keywords

Prevention strategy; Cutaneous toxicity; Quality of life; Patient satisfaction; Dermatology Life Quality Index (DLQI); Epidermal Repair Score (SCOREPI); Topical treatment

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Overall patient satisfaction after 60 days treatment

  After 60 days of treatment or at the end of treatment for patient who interrupt the treatment before 60 days

• Patient Quality of life

  At inclusion, after 30 and 60 days of treatment

• Cutaneous toxicities evaluation 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

  After 15, 30 and 60 days of treatment

• Modification/Interruption/Discontinuing iEGFR treatment rate

  Continuously up to 30 days after starting treatment

Study Arms (2)

Arm A : Cicaplast balm B5

EXPERIMENTAL

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

Arm B : Dexeryl

ACTIVE COMPARATOR

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

Interventions

Cicaplast Balm B5 OTHER

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

Arm A : Cicaplast balm B5

Dexeryl OTHER

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

Arm B : Dexeryl

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• Centre Leon Berard: lead

Study Sites (1)

Centre Léon Bérard

Lyon, Rhône, 69008, France

Location

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Colorectal Neoplasms; Carcinoma, Non-Small-Cell Lung; Patient Satisfaction

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Diseases; Respiratory Tract Diseases; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Jérôme FAYETTE, Doctor

  Centre Léon Bérard, Lyon, France

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Arm A : Use of Cicaplast balm B5 since de first day of iEGFR initiation treatment for 30 days Arm B : Use of Dexeryl cream since de first day of iEGFR initiation treatment for 30 days

Study Record Dates

• First Submitted: January 29, 2018
• First Posted: February 5, 2018
• Study Start: February 16, 2018
• Primary Completion: April 11, 2021
• Study Completion: May 11, 2021
• Last Updated: July 9, 2021

Record last verified: 2021-07

Locations

FR (1)