The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
Primary Purpose
Breast Cancer, Radiation Dermatitis
Status
Unknown status
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
RadiaAce gel
Biafine
Sponsored by
About this trial
This is an interventional prevention trial for Breast Cancer focused on measuring Radiation dermatitis, breast cancer
Eligibility Criteria
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
Sites / Locations
- AssutaRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
RadiaAce gel
Biafine
Arm 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).
one of the standard skin care in radiation oncology, this treatment was chosen as the comparator.
Outcomes
Primary Outcome Measures
Skin assessment (RD grade)
Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring
Pain (VAS)
Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment
Patient's assessment of the skin condition (DLQI questioner)
The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04481802
Brief Title
The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
Official Title
The Effect of RadiaAce Gel Versus Biafine in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
July 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 14, 2021 (Actual)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
October 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AceTech
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Radiation Dermatitis
Keywords
Radiation dermatitis, breast cancer
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
RadiaAce gel
Arm Type
Experimental
Arm 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).
Arm Title
Biafine
Arm Type
Active Comparator
Arm Description
one of the standard skin care in radiation oncology, this treatment was chosen as the comparator.
Intervention Type
Device
Intervention Name(s)
RadiaAce gel
Other Intervention Name(s)
Acemannan hydrogel
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Biafine
Intervention Description
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.
Primary Outcome Measure Information:
Title
Skin assessment (RD grade)
Description
Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring
Time Frame
10 weeks
Title
Pain (VAS)
Description
Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment
Time Frame
10 weeks
Title
Patient's assessment of the skin condition (DLQI questioner)
Description
The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)
Time Frame
10 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sivan Luder, VP R&D
Phone
0508490794
Email
Sivan@acemanan-tech.com
First Name & Middle Initial & Last Name or Official Title & Degree
Dana Shwartz, CA
Phone
+972507509103
Email
dana@acemanan-tech.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Meirav Ben David, MD
Organizational Affiliation
Director of radiotherapy Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Assuta
City
Tel Aviv
State/Province
Tel Aviv District
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hava Evelyn Klotz
Phone
+972-542196153
Email
havakl@assuta.co.il
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
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