Use of Gelronate Gel vs. Aloevera in Preventing/Minimizing Radiation-induced Dermatitis in Breast Cancer Patients
NCT ID: NCT03941665
Last Updated: 2020-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
136 participants
INTERVENTIONAL
2019-03-25
2020-05-03
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Gelronate
Tested new medical device
Gelronate
Gel for topical use
Aloevera
Gel for topical use
Aloevera
Current product used by the medical center
Gelronate
Gel for topical use
Aloevera
Gel for topical use
Interventions
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Gelronate
Gel for topical use
Aloevera
Gel for topical use
Eligibility Criteria
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Inclusion Criteria
* 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
* Prior radiotherapy to the chest wall.
* Collagen vascular disease.
* Participation in other clinical study.
18 Years
FEMALE
No
Sponsors
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Ferring Pharmaceuticals
INDUSTRY
Sheba Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Ofer S Dubinsky, Ph.D.
Role: STUDY_DIRECTOR
Ferring Holding Ltd.
Locations
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Sheba Medical Center
Ramat Gan, , Israel
Countries
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References
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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.
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.
Provided Documents
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Document Type: Study Protocol
Other Identifiers
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5652-18-SMC
Identifier Type: -
Identifier Source: org_study_id