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

Sponsor

AceTech (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04481802

Collaborator

(none)

120

Enrollment

Location

Arms

14.6

Anticipated Duration (Months)

8.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer Radiation Dermatitis	Device: RadiaAce gel Device: Biafine	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

120 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Actual Study Start Date :

Jul 14, 2021

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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).	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. Other Names: Acemannan hydrogel
Active Comparator: Biafine one of the standard skin care in radiation oncology, this treatment was chosen as the comparator.	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.

Arm

Intervention/Treatment

Experimental: 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).

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.

Other Names:

Acemannan hydrogel

Active Comparator: Biafine

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

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.

Outcome Measures

Primary Outcome Measures

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)

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Female patients
Age > 18
Patients with histologically-confirmed diagnosis of breast cancer
Patients after breast lumpectomy and that scheduled to receive radiotherapy
Patients to receive minimum of 40.05 Gy to primary field
Must be able to comply with treatment schedule
Study-specific signed informed consent prior to randomization

Exclusion Criteria:

Inflammatory or connective tissue disorders of the skin
Mental incompetence, including psychological or addictive disorders which would preclude completion of questionnaires
Previous radiation therapy to the breast
Tumour involvement of the skin
Rash, ulceration or open wound in treatment field
Known skin allergy or sensitivity to Aloe Vera or Biafine
Current lactation
Pregnancy
Any other reason that, in the opinion of the investigator, prevents the subject from