The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
NCT ID: NCT04481802
Last Updated: 2021-07-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
120 participants
INTERVENTIONAL
2021-07-14
2022-10-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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).
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.
Biafine
one of the standard skin care in radiation oncology, this treatment was chosen as the comparator.
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.
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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
18 Years
120 Years
FEMALE
No
Sponsors
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AceTech
INDUSTRY
Responsible Party
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Principal Investigators
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Meirav Ben David, MD
Role: PRINCIPAL_INVESTIGATOR
Director of radiotherapy Institute
Locations
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Assuta
Tel Aviv, Tel Aviv, Israel
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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RadiaAce001
Identifier Type: -
Identifier Source: org_study_id
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