Use of Gelronate Gel vs. Aloevera in Preventing/Minimizing Radiation-induced Dermatitis in Breast Cancer Patients

Not Applicable

Completed

• Conditions: Radiation Dermatitis
• Interventions: Device: Gelronate; Other: Aloevera

• Registration Number: NCT03941665
• Lead Sponsor: Sheba Medical Center

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.

Study Timeline

• Study Start: 2019-03-25
• Study First Submitted: 2019-05-02
• Study First Submitted QC: 2019-05-05
• Study First Posted: 2019-05-08
• Status Verified: 2019-12
• Primary Completion: 2020-05-01
• Study Completion: 2020-05-03
• Last Update Submitted: 2020-12-02
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 136

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aloevera	Aloevera	Current product used by the medical center
Aloevera	Gelronate	Current product used by the medical center
Gelronate	Gelronate	Tested new medical device
Gelronate	Aloevera	Tested new medical device

Primary Outcome Measures

Name	Time	Method
Development and degree of any skin reaction	4 weeks	Patient comfort assessed by weekly administrated questionnaire. Scores are between 1 (nothing) to 4 (all over the breast)

Secondary Outcome Measures

Name	Time	Method
Skin reaction requiring conventional topical therapy	4 weeks	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))

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel