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

Radiation Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03941665
• Other study ID #: 5652-18-SMC
• Status: Completed
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

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