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

Not Applicable

• Conditions: Radiation Dermatitis; Breast Cancer
• Interventions: Device: RadiaAce gel; Device: Biafine

• Registration Number: NCT04481802
• Lead Sponsor: AceTech

Brief 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-06-07
• Study First Submitted QC: 2020-07-19
• Study First Posted: 2020-07-22
• Status Verified: 2021-07
• Study Start: 2021-07-14
• Last Update Submitted: 2021-07-20
• Last Update Posted: 2021-07-21
• Primary Completion: 2022-07
• Study Completion: 2022-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
RadiaAce gel	RadiaAce gel	RadiaAce Gel is a clear, non-oily Hydrogel wound dressing for the management of Radiation Dermatitis which provides optimal moist wound environment necessary to the healing process. RadiaAce gel contains Acemannan, a high molecular polysaccharide obtained from the inner gel of Aloe Vera leaves and it is considered the main functional component of Aloe vera (Sahu et al. 2013).
Biafine	Biafine	one of the standard skin care in radiation oncology, this treatment was chosen as the comparator.

Primary Outcome Measures

Name	Time	Method
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
Patient's assessment of the skin condition (DLQI questioner)	10 weeks	The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)
Pain (VAS)	10 weeks	Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment

Trial Locations

Locations (1)

Assuta; 🇮🇱 Tel Aviv, Tel Aviv District, Israel