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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04481802
• Other study ID #: RadiaAce001
• Status: Recruiting
• Phase: N/A
• Start date: July 14, 2021
• Est. completion date: October 2022

Study information

• Verified date: July 2021
• Source: AceTech
• Contact: Sivan Luder, VP R&D
• Phone: 0508490794
• Email: Sivan[@]acemanan-tech.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: October 2022
• Est. primary completion date: July 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 120 Years

Eligibility

Inclusion Criteria:

1. Female patients

2. Age > 18

3. Patients with histologically-confirmed diagnosis of breast cancer

4. Patients after breast lumpectomy and that scheduled to receive radiotherapy

5. Patients to receive minimum of 40.05 Gy to primary field

6. Must be able to comply with treatment schedule

7. Study-specific signed informed consent prior to randomization

Exclusion Criteria:

1. Inflammatory or connective tissue disorders of the skin

2. Mental incompetence, including psychological or addictive disorders which would preclude completion of questionnaires

3. Previous radiation therapy to the breast

4. Tumour involvement of the skin

5. Rash, ulceration or open wound in treatment field

6. Known skin allergy or sensitivity to Aloe Vera or Biafine

7. Current lactation

8. Pregnancy

9. Any other reason that, in the opinion of the investigator, prevents the subject from

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Dermatitis
• Radiation Dermatitis
• Radiodermatitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
Israel	Assuta	Tel Aviv	Tel Aviv District

Sponsors (1)

Lead Sponsor	Collaborator
AceTech

Country where clinical trial is conducted

Israel, 

Outcome

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