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

Not Applicable

Completed

Conditions: Radiodermatitis
Dermatitis, Radiation-Induced

Interventions: Device: DermoRelizema cream
Device: Dexeryl

Registration Number: NCT04483856

Lead Sponsor: Relife Italia S.r.l.

Brief Summary: 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

Detailed Description: 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

Recruitment & Eligibility

Status: COMPLETED

Sex: Female

Target Recruitment: 70

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DermoRelizema cream	DermoRelizema cream	The treatment will be applied since about 7 (±3) days prior to RT start and will continue until 14 days post RT end
Dexeryl	Dexeryl	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).

Primary Outcome Measures

Name	Time	Method
Number of Participants With Progression of Radio Therapy Induced Skin Reaction	two weeks after the last RT sessiont,day 35-42	Evaluation of the effects of DermoRelizemaTM cream in the management of the progression of RT-induced skin reactions and toxicity

Secondary Outcome Measures

Name	Time	Method
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)	at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 56	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)
Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)	up to 1 year	Evaluation of dermatitis symptoms management
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)	all study visits, day 21-28, day 35-42 and at the study end (day 49-56)	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
Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale	all study visits, day 21-28, day 35-42 and at the study end (day 49-56)	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)
Number of Participants With Progression of Radio Therapy Induced Skin Reaction	all study visits, day 21-28, day 35-42 and at the study end (day 49-56)	Objective instrumental assessments of skin damage vascular parameters, tissue integrity and structural parameters,
Patient Opinion on Cream With a Likert Scale	up to 1 year	Overall patient's opinion on the products' pleasantness
Adherence to Treatment of Patients	up to 1 year	Patient's adherence to treatment on a diary's scale ( 10 points, in whitc: 1 is the best, 100 is the worst)
Occurrence of Adverse Events	up to 1 year	Occurrence of Adverse Events