The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
The Effect of RadiaAce Gel Versus Biafine in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
1 other identifier
interventional
120
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable breast-cancer
Started Jul 2021
Shorter than P25 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 7, 2020
CompletedFirst Posted
Study publicly available on registry
July 22, 2020
CompletedStudy Start
First participant enrolled
July 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2022
CompletedJuly 21, 2021
July 1, 2021
12 months
June 7, 2020
July 20, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Skin assessment (RD grade)
Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring
10 weeks
Pain (VAS)
Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment
10 weeks
Patient's assessment of the skin condition (DLQI questioner)
The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)
10 weeks
Study Arms (2)
RadiaAce gel
EXPERIMENTALRadiaAce 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
ACTIVE COMPARATORone of the standard skin care in radiation oncology, this treatment was chosen as the comparator.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AceTechlead
Study Sites (1)
Assuta
Tel Aviv, Tel Aviv, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Meirav Ben David, MD
Director of radiotherapy Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 7, 2020
First Posted
July 22, 2020
Study Start
July 14, 2021
Primary Completion
July 1, 2022
Study Completion
October 1, 2022
Last Updated
July 21, 2021
Record last verified: 2021-07
Data Sharing
- IPD Sharing
- Will not share