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

July 20, 2021 updated by: AceTech

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Israel
    • Tel Aviv District
      • Tel Aviv, Tel Aviv District, Israel
        • Recruiting
        • Assuta
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 120 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AceTech

Investigators

  • Principal Investigator: Meirav Ben David, MD, Director of radiotherapy Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 14, 2021

Primary Completion (ANTICIPATED)

July 1, 2022

Study Completion (ANTICIPATED)

October 1, 2022

Study Registration Dates

First Submitted

June 7, 2020

First Submitted That Met QC Criteria

July 19, 2020

First Posted (ACTUAL)

July 22, 2020

Study Record Updates

Last Update Posted (ACTUAL)

July 21, 2021

Last Update Submitted That Met QC Criteria

July 20, 2021

Last Verified

July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RadiaAce001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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