Clinical trial NCT03941665: Use of Gelronate Gel vs. Aloevera in Preventing/Minimizing Radiation-induced Dermatitis in Breast Cancer Patients
Official title: Double Blind Study - Use of Gelronate Gel vs. Aloevera in Preventing/Minimizing Radiation-induced Dermatitis in Breast Cancer Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Radiation Dermatitis
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
Collaborators: name: Ferring Pharmaceuticals
First posted: 2019-05-08
Enrollment: 136
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double blind study
Primary purpose: PREVENTION

Brief summary: The aim of the study is to evaluate the effect of Gelronate gel, NaHA based product (medical device for topical application) vs. Aloevera gel, in prevention or minimizing of radiation induced skin reaction in breast cancer patients

Detailed description: Gelronate is gel composed of 1% high molecular weight pharmaceutical grade sodium hyaluronate and preservatives dissolved in pharmaceutical grade purified water. Gelronate supply in an airless pump bottle contain \~30 ml gel. In the study, 120 female patients planned to receive whole breast radiation (with or without lymphatic drainage) in the radiotherapy unit at Sheba Medical Center.

Patients will undergo CT simulation with 3D treatment planning (as routine done) and will receive 42.4 Gy in daily fraction of 2.65 Gy, five times per week to the whole breast according to the standard department protocol, with or without concomitant or subsequent lumpectomy cavity boost. Patients data including demographics, staging, systemic therapy, radiation details, other medications will be recorded the protocol's forms.

The gel will be applied as a thin lotion twice a day, immediately after radiotherapy treatment and once more in the evening/morning. The therapy will continue for 10 days following the end of radiation therapy.

Eligibility criteria: Inclusion Criteria:

* Female patients aged at least 18 years with unilateral breast following lumpectomy +/- chemotherapy
* Planned to receive 42.4 Gy whole breast irradiation +/- boost to tumor bed.
* ECOG performance status 0-2.
* Capable of giving written informed consent.
* No co-morbidities known to affect radiotherapy reactions.
* No co-existing acute or chronic skin disease.
* No evidence of infection or inflammation of breast to be treated.
* Not receiving chemotherapy during radiotherapy course. Biological therapy (e.g. Herceptin) or hormone therapy will be allowed during the study.

Exclusion Criteria:

* Chemotherapy within 4 weeks prior to planned start of radiation or chemotherapy planned during radiation.
* Prior radiotherapy to the chest wall.
* Collagen vascular disease.
* Participation in other clinical study.

Primary outcomes:
measure: Development and degree of any skin reaction
timeFrame: 4 weeks
measure: Development and degree of any skin reaction
timeFrame: 4 weeks
measure: Development and degree of any skin reaction
timeFrame: 4 weeks
Secondary outcomes:
measure: Skin reaction requiring conventional topical therapy
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Ferring Holding Ltd.
name: Ofer S Dubinsky, Ph.D.
role: STUDY_DIRECTOR
References:
citation: Primavera G, Carrera M, Berardesca E, Pinnaro P, Messina M, Arcangeli G. A double-blind, vehicle-controlled clinical study to evaluate the efficacy of MAS065D (XClair), a hyaluronic acid-based formulation, in the management of radiation-induced dermatitis. Cutan Ocul Toxicol. 2006;25(3):165-71. doi: 10.1080/15569520600860009.
citation: Leonardi MC, Gariboldi S, Ivaldi GB, Ferrari A, Serafini F, Didier F, Mariani L, Castiglioni S, Orecchia R. A double-blind, randomised, vehicle-controlled clinical study to evaluate the efficacy of MAS065D in limiting the effects of radiation on the skin: interim analysis. Eur J Dermatol. 2008 May-Jun;18(3):317-21. doi: 10.1684/ejd.2008.0396. Epub 2008 May 13.