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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03941665
Other study ID # 5652-18-SMC
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 25, 2019
Est. completion date May 3, 2020

Study information

Verified date December 2019
Source Sheba Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


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.


Recruitment information / eligibility

Status Completed
Enrollment 136
Est. completion date May 3, 2020
Est. primary completion date May 1, 2020
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Gelronate
Gel for topical use
Other:
Aloevera
Gel for topical use

Locations

Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (2)

Lead Sponsor Collaborator
Sheba Medical Center Ferring Pharmaceuticals

Country where clinical trial is conducted

Israel, 

References & Publications (2)

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: — View Citation

Primavera G, Carrera M, Berardesca E, Pinnaró 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 — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary Development and degree of any skin reaction Assessment of skin reaction by scoring of weekly digital photographs 4 weeks
Primary 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
Secondary 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)) 4 weeks
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