Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

A forward planned IMRT technique was used and the prescribed dose to the whole breast was 50 Gy plus a concomitant boost of 10 Gy to the tumor bed

The whole breast received 50.4 Gy in 28 fractions delivered with 3D-RT, followed by a sequential boost on the tumor bed of 10 Gy in 4 fractions delivered with electrons

IMRT with concomitant boost

3D-RT with sequential boost

Alessio G Morganti, MD

To assess feasibility of postoperative IMRT with concomitant boost in moderate-high risk breast cancer in terms of late toxicity and local control

Patients treated conservatively with moderate-high risk breast cancer were treated with IMRT plus concomitant boost to surgical bed (up to a dose of 50 Gy to whole breast and 60 Gy to the tumor bed).

Aim of the study was to evaluate late toxicity and local control after this treatment compared with a historical control group (CG) of patients treated with 3D-conformal postoperative radiotherapy delivered with conventional fractionation.

Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer

Moderated Accelerated RAdiotherapy (MARA-2) in Moderate-high Risk Breast Cancer: a Phase I-II Study

late toxicity (cutaneous and subcutaneous) is evaluated using RTOG/EORTC criteria in both groups of patients

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Digestive System Diseases

Behaviors and Mental Disorders

Lung Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma

Carcinoma, Squamous Cell

Colorectal Neoplasms

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Head and Neck Neoplasms

Quality of Life

All Drugs and Chemicals

Herbal and Botanical

Mitogens

Lemon Balm

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.

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.

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

Cicaplast Balm B5

Dexeryl

Jérôme FAYETTE, Doctor

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

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

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

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)

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

Overall patient satisfaction toward Cicaplast balm B5 or Dexeryl will be evaluated by a numerical scale from 0 to 10 in each arm

Quality of life of patient will be evaluated by using the Dermatology Life Quality Index questionnaire (DLQI) in each arm

Cutaneous toxicities will be evaluated in each arm by using Epidermal Repair Score (SCOREPI)

Cutaneous toxicities will be evaluated in each arm by using Common Terminology Criteria for Adverse Events (CTCAE) version 4

Modification/Interruption/Discontinuing iEGFR treatment rate in each arm because of cutaneous toxicity

Evaluation of DLQI (patient evaluation) and SCOREPI (investigator evaluation) scores correlation in each arm

Topical observance will be evaluated in each arm by data collection by each patient in a diary

Evaluation of the rate of patients needing to use dermocorticoids.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Intensity Modulated Radiotherapy With Concomitant Boost in Breast Cancer	NCT03471741	Breast Cancer Radiation Toxic...	IMRT with conco... 3D-RT with sequ...	-	IRCCS Azienda Ospedaliero-Universitaria di Bologna
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	Head and Neck S... Colorectal Canc... Non Small Cell ... Epidermal Growt...	Cicaplast Balm ... Dexeryl	18 Years -	Centre Leon Berard

Spots Global Cancer Trial Database for cutaneous toxicity