Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.

Relife Italia S.r.l.70 enrolled

Overview

This is a post marketing, interventional, randomized, single-center, prospective, controlled study, for the evaluation of the clinical performance and tolerability of a cream-based medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women with breast cancer. Assessments and evaluations will be performed by a physician in a blind fashion. The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity, using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC), at the conclusion of the treatment period

This is a post marketing, interventional, randomized, single-center, prospective, controlled study, for the evaluation of the clinical performance and tolerability of a cream-based medical device (DermoRelizemaTM cream) in the management care of radiodermatitis in women with breast cancer. Assessments and evaluations will be performed by a physician in a blind fashion. The aim of this clinical study is to collect controlled evidences of the effectiveness and tolerability of DermoRelizemaTM cream in the management of RISRs in patients with breast cancer who will start the treatment with the product about one week before the start of RT. The primary objective is Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity, using the grading system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC), at the conclusion of the treatment period

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Interventions

DermoRelizema creamDEVICE

Fingertip units (FTU) depending from the extent of the affected skin to treat, two times per day for 7 (±3) days prior RT until about 14 (±3) days post RT end. The product can be used for further 2 weeks (from V3 to V4) in case of need, according to the investigator's judgment

DexerylDEVICE

FTUs depending on the extent of the affected skin to treat, two times per day. The treatment will be applied since 7 (±3) days prior to RT start and will continue until 14 days post RT end (98-112 applications in total).

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Women who give their written consent for participation in the study and willing to comply with all its procedures. * Age ≥18 years. * Women with breast cancer at any stage who have undergone quadrantectomy, for whom hypofractionated adjuvant RT of the thoracic region is indicated. * RTOG/ EORTC radiodermatitis grade equal to 0 (zero) and good cutaneous trophism, in the region to be treated, according to investigator's judgement. * Patients who are supposed to be cooperative with regard to compliance with study-related constraints. Exclusion Criteria: * Pregnant or lactating women (as not eligible to RT), and fertile women not following, at the investigators' judgement, an adequate contraceptive method. * Subjects incapable of giving consent. * Concomitant inflammatory skin diseases in acute phase such as: atopic dermatitis, contact dermatitis, psoriasis, lichen planus, pityriasis rosea. * Collagen vascular disease, vasculitis, scleroderma, dermatomyositis, or systemic lupus erythematosus. * Unhealed surgical sites, breast infections. * Bilateral breast cancer or multiple neoplasia needing other independent RT treatments. * Prior breast reconstructions, implants, and/or expanders. * Known radio-sensitivity syndromes (e.g. ataxia-telangiectasia). * Known history of intolerance or hypersensitivity to any ingredient of the study products. * Previous RT in the same or different location. * Topical pharmacological and medical device treatments on the skin region affected by the RT, in the last 2 weeks. * Systemic or topical (including inhaled or intranasal) treatments containing corticosteroids of any class in the 2 days preceding the enrolment. * Photo-therapy (PUVA, UVB) in the 2 weeks preceding the enrolment and/or planned to be administered during the course of the study. * Participation in another clinical trial at the time of the randomization or within 28 days before randomization. * Patient's difficulties or problems, in the judgment of the investigator, in being compliant with study procedures and requirements, including social or mental constrains.

Outcomes

Primary Outcomes

Number of Participants With Progression of Radio Therapy Induced Skin Reaction

Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity

Time frame: two weeks after the last RT sessiont,day 35-42

Secondary Outcomes

Progression of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

1\. Evaluation of the effects of DermoRelizemaTM cream, in the management of the progression of RT-induced skin reactions and toxicity, using the (RTOG/ EORTC) at the conclusion of the radiotherapy treatment (V2) and at study end (V4)

Time frame: at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 56

Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)

Evaluation of dermatitis symptoms management

Time frame: up to 1 year

Severity of Radio Therapy-induced Skin Reactions Using the Grading System of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer (RTOG/ EORTC)

Evaluation of the severity of radiation dermatitis by the investigator using the RTOG/ EORTC (system of the Radiation Therapy Oncology Group / European Organization for Research and Treatment of Cancer(grade 0-1: treatment is succesfull, grade 1 or magior: treatment insuccesful) ), at visits 2, 3 and 4

Time frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)

Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale

Evaluation of the severity of radiation dermatitis by the investigator using the Radiation Dermatitis Severity (RDS) scoring scale. The severity of radiation dermatitis was measured using this scoring system, range 0.0 to 4.0 at increments of 0.5. The RDS score incorporates changes in redness, pigment, texture and integrity of the skin ( grade 0: best result, grade 4§: worst result)

Time frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)

Number of Participants With Progression of Radio Therapy Induced Skin Reaction

Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters,

Time frame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)

Patient Opinion on Cream With a Likert Scale

Overall patient's opinion on the products' pleasantness

Time frame: up to 1 year

Adherence to Treatment of Patients

Patient's adherence to treatment on a diary's scale ( 10 points, in whitc: 1 is the best, 100 is the worst)

Time frame: up to 1 year

Occurrence of Adverse Events

Time frame: up to 1 year

Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes

Secondary Outcomes