NCT04481802

The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients

The Effect of RadiaAce Gel Versus Biafine in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: AceTech · Industry
• Sex: Female
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

Radiation dermatitis (RD) is one of the most common side effects of Radiation therapy (RT) and 95% of patients receiving RT may experience some form of radiation dermatitis. A wide variety of topical, oral, and intravenous agents are used to prevent/treat Radiation dermatitis but currently there is no gold standard in the prevention and management of this condition and no treatment can be explicitly recommended. RadiaAce Gel is a wound dressing Hydrogel (Acemannan Hydrogel) for the management of RD which provides optimal moist wound environment necessary to the healing process. Based on its composition as well as the supporting data on safety and performance of the functional ingredient Acemannan in wound healing, RadiaAce may well be suited to complement the prevention and therapy of radiation dermatitis. The primary aim of the study is to evaluate the safety and performance of RadiaAce as compare to Biafine in reducing the proportion of breast cancer patients that experience grade 2 or higher RD as measured by the RTOG scoring system

Conditions

• Breast Cancer
• Radiation Dermatitis

Interventions

Type	Name	Description
DEVICE	RadiaAce gel	Patients will apply the RadiaAce to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.
DEVICE	Biafine	Patients will apply the Biafine to the treatment area starting 5 days before radiation treatment. The Hydrogel/cream will be applied three times a day with a minimum of four hours between applications. Treatments will be used through the course of RT and for 6 days after the last fraction of radiation.

Timeline

• Start date: 2021-07-14
• Primary completion: 2022-07-01
• Completion: 2022-10-01
• First posted: 2020-07-22
• Last updated: 2021-07-21

Locations

1 site across 1 country: Israel