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

NCT04481802 NA UNKNOWN

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

Details

Lead sponsor	AceTech
Phase	NA
Status	UNKNOWN
Enrolment	120
Start date	2021-07-14
Completion	2022-10

Conditions

• Breast Cancer
• Radiation Dermatitis

Interventions

• RadiaAce gel
• Biafine

Primary outcomes

• Skin assessment (RD grade) — 10 weeks
  Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring
• Pain (VAS) — 10 weeks
  Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment
• Patient's assessment of the skin condition (DLQI questioner) — 10 weeks
  The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)

Countries

Israel