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

AceTech

Status: Unknown

Conditions: Breast Cancer; Radiation Dermatitis

Treatments: Device: Biafine; Device: RadiaAce gel

Study type: Interventional

Funder types: Industry

Identifiers

NCT04481802

RadiaAce001

Details and patient eligibility

About

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

Enrollment: 120 estimated patients

Sex: Female

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

120 participants in 2 patient groups

RadiaAce gel

Experimental group

Description:

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).

Treatment:

Device: RadiaAce gel

Biafine

Active Comparator group

Description:

one of the standard skin care in radiation oncology, this treatment was chosen as the comparator.

Treatment:

Device: Biafine