Breast CancerNCT04481802
The Effect of RadiaAce Gel in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
A study testing RadiaAce gel and Biafine in people with Breast Cancer and Radiation Dermatitis, run by AceTech at 1 site in Israel.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years, women only
- Conditions the study is for
- Breast Cancer, Radiation Dermatitis
- What is being tested?
- RadiaAce gel and Biafine
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteIsrael
- Study dates
- 14 Jul 2021to Oct 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- Current lactation
- Pregnancy
- Any other reason that, in the opinion of the investigator, prevents the subject from
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Assuta
Tel Aviv, Tel Aviv
Hava Evelyn Klotz, +972-542196153, havakl@assuta.co.il
About this study
Official title: 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.
Read more
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
- Conditions
- Breast Cancer, Radiation Dermatitis
- Being tested
- RadiaAce gel, Biafine
- Keywords
- Radiation dermatitis, breast cancer
- Medical subject headings
- Breast Neoplasms, Radiodermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiaAce gelDevice
Also called Acemannan hydrogel
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.
BiafineDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| RadiaAce gel | Experimental | 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). Receives: Device: RadiaAce gel |
| Biafine | Active comparator | one of the standard skin care in radiation oncology, this treatment was chosen as the comparator. Receives: Device: Biafine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin assessment (RD grade)
Skin condition (grade of RD) in the radiation area will be measured by the Radiation Therapy Oncology Group (RTOG) scoring
Measured: 10 weeks
Pain (VAS)
Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment
Measured: 10 weeks
Patient's assessment of the skin condition (DLQI questioner)
The Patients perspective is captured by the Dermatology Life Quality Index (DLQI)
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2020
- Study start14 Jul 2021
- Primary completionJul 2022 (estimated)
- Study completionOct 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AceTech
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Meirav Ben David, MD, Principal investigator, Director of radiotherapy Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04481802
- Sponsor's protocol ID
- RadiaAce001
- Status last verified
- Jul 2021
- First submitted
- 7 Jun 2020
- Last updated
- 21 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of RadiaAce Gel Versus Biafine in the Prevention and Treatment of Radiation Dermatitis in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT04481802
- Acronym / sponsor ID
- RadiaAce001
- Conditions
- Breast Cancer, Radiation Dermatitis
- Keywords
- Radiation dermatitis, breast cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- AceTechIndustry (pharma, biotech, devices)
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Oct 2022 (estimated)
- First posted
- 22 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RadiaAce gel | Experimental | Device: RadiaAce gelRadiaAce 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 comparator | Device: Biafineone of the standard skin care in radiation oncology, this treatment was chosen as the comparator. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RadiaAce gelAlso: Acemannan hydrogelPatients 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. | Device | RadiaAce gel |
| BiafinePatients 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. | Device | Biafine |
Primary outcome
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
Pain (VAS)
Time frame: 10 weeks
Dermatitis-related pain is assessed with a visual analogue scale (VAS) self-assessment
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Meirav Ben David, MD principal investigator
Director of radiotherapy Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RadiaAce gel and Biafine in people with Breast Cancer and Radiation Dermatitis, run by AceTech at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sivan Luder, VP R&D (0508490794, Sivan@acemanan-tech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Skin assessment (RD grade) (time frame: 10 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jul 2021.