Clinical trial NCT04483856: Efficacy and Tolerability Evaluation of a Topical MD Based on SHBF in Management of Radiodermatitis.
Official title: Efficacy and Tolerability Evaluation of a Topical Medical Device Based on SHBF in Management of Radiodermatitis. An Observer-masked, Controlled Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiodermatitis
Dermatitis, Radiation-Induced
Keywords: Radiodermatitis
DermoRelizema cream
DRESDA
Sodium Hyaluronate Butyrate Formiate
RELIFE
Lead sponsor: Relife Italia S.r.l.
Sponsor class: INDUSTRY
First posted: 2020-07-23
Enrollment: 70
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a post marketing, interventional, randomized, single-center, prospective, controlled study. Assessments and evaluations will be performed by a physician in a blind fashion.
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Number of Participants With Progression of Radio Therapy Induced Skin Reaction
timeFrame: two weeks after the last RT sessiont,day 35-42
Secondary outcomes:
measure: 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)
timeFrame: at the conclusion of the radiotherapy treatment, day 21-28 and at the study end day 49-56, reported day 56
measure: Evaluation of the Radiation Symptoms (0 Best Result, 40 Worst Results)
timeFrame: up to 1 year
measure: 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)
timeFrame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
measure: Severity of Radiation Dermatitis With Radiation Dermatitis Severity (RDS) Scoring Scale
timeFrame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
measure: Number of Participants With Progression of Radio Therapy Induced Skin Reaction
timeFrame: all study visits, day 21-28, day 35-42 and at the study end (day 49-56)
measure: Patient Opinion on Cream With a Likert Scale
timeFrame: up to 1 year
measure: Adherence to Treatment of Patients
timeFrame: up to 1 year
measure: Occurrence of Adverse Events
timeFrame: up to 1 year
Other outcomes:
Locations:
city: Modena
country: Italy
facility: Modena University Hospital
Study officials:
affiliation: University of Modena
name: Mariangela Francomano
role: PRINCIPAL_INVESTIGATOR
References: