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

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Double Blind Study - Use of Gelronate Gel vs. Aloevera in Preventing/Minimizing Radiation-induced Dermatitis in Breast Cancer Patients

Conditions
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Radiation Dermatitis

Intervention / Treatment
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* Device: Gelronate
* Other: Aloevera


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double blind study
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gelronate<br>Tested new medical device | Device: Gelronate<br>* Gel for topical use<br>Other: Aloevera<br>* Gel for topical use<br>|
| Active Comparator: Aloevera<br>Current product used by the medical center | Device: Gelronate<br>* Gel for topical use<br>Other: Aloevera<br>* Gel for topical use<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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)) | 4 weeks |