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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Gelronate | Experimental | Tested new medical device |
|
| Aloevera | Active Comparator | Current product used by the medical center |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Gelronate | Device | Gel for topical use |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Development and degree of any skin reaction | Grading according to Radiation Toxicity Grading (RTOG) skin toxicity score. Full scale of RTOG is 0 (no change over baseline) to 4 (ulceration, hemorrhage, necrosis). | 4 weeks |
| Development and degree of any skin reaction | Assessment of skin reaction by scoring of weekly digital photographs | 4 weeks |
| Development and degree of any skin reaction | Patient comfort assessed by weekly administrated questionnaire. Scores are between 1 (nothing) to 4 (all over the breast) | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Skin reaction requiring conventional topical therapy | Skin reaction requiring conventional topical therapy (e.g. steroid cream etc.) as evaluated by clinical. judgment of radiotherapy nurse/radiation oncologist at OTV (on treatment view visit that will include RTOG (Radiation Toxicity Grading) scores (in the range 0 no change to 4 ulceration, hemorrhage, necrosis) and dermatology assessment according to the table in the protocol (general view range 1 (nothing) to 4 (continuous)) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ofer S Dubinsky, Ph.D. | Ferring Holding Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sheba Medical Center | Ramat Gan | 5265601 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16980242 | Result | 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. | |
| 18474463 |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 7, 2019 | May 29, 2019 | Prot_000.pdf |
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| ID | Term |
|---|---|
| D011855 | Radiodermatitis |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D011832 | Radiation Injuries |
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Double blind study
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Double blind study
| Aloevera |
| Other |
Gel for topical use |
|
| 4 weeks |
| 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. |
| D014947 |
| Wounds and Injuries |