Breast CancerEarly Phase 1ARDNCT01923220
Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis
A Early Phase 1 study testing HO/02/02 20µg and Aloe Vera Jel in people with Breast Cancer, run by HealOr at 1 site in Israel.
Trial summary
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- HO/02/02 20µg and Aloe Vera Jel
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteIsrael
- Study dates
- Sep 2013to Dec 2014
- Phase
- Early Phase 1
- 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 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients 18 years old and above.
- Histology confirmed unilateral breast cancer following lumpectomy
- Planned to receive 50 Gy, whole breast XRT and regional lymph nodes radiation.
- ECOG performance status 0-2
- Completed Chemotherapy 3 weeks prior to XRT (if applicable)
- Patient should be available for the entire study period, and be able and willing to adhere to protocol requirements;
- Patient must sign an informed consent form prior to undergoing any study-related procedures
Who cannot join
- Known uncontrolled diabetes
- Prior radiation to breast
- Known connective tissue disorder
- Known skin disease over the treated breast
- Prior burn over treated area
- Evidence of infection or inflammation of breast to be treated.
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- Receiving biological therapy or hormone therapy (other than Herceptin) during radiation treatment/study duration and 4 weeks prior to study entry.
- Pre-existing skin breakdown within the planned radiotherapy field at the time of study entry.
- Pregnancy, planned pregnancy, lactation or inadequate contraception as judged by the Investigator.
- Participation in another investigational drug or vaccine trial concurrently or within 30 days.
- Use of any other topical or systemic treatments aimed at radiation dermatitis.
- Use of a prescription or over-the-counter medication that contains hydrocortisone or any other cortisone or corticosteroid containing preparation
Trial locations and contacts
1 site in 1 country.
Israel1 site
The Chaim Sheba Medical Center
Ramat Gan, 52621
Ilanit Dromi, +972-544943210, ilanit_2@walla.com
Merav Ben-David, M.D.
About this study
Official title: An Open-Label, Randomized Study to Evaluate the Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis In Breast Cancer Patients Undergoing Radiation Therapy.
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment
Read the detailed description
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment in addition to sterile water for irrigation applied daily for 15 minutes (with gauze) on treatment fields to create the same cooling effect as in treatment arm 1. Both treatment arms 1\&2 treatments will be applied topically once daily for up to 8 weeks to reduce radiation dermatitis in up to 90 breast cancer patients undergoing adjuvant radiation therapy.
- Conditions
- Breast Cancer
- Being tested
- HO/02/02 20µg, Aloe Vera Jel
- Keywords
- Breast Cancer, Radiation Therapy, Radiation Dermatitis
- 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.
HO/02/02 20µgDrug
Interventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily
Aloe Vera JelOther
To be applied topically once daily
| Study group | Role | What they receive |
|---|---|---|
| HO/02/02 | Experimental | Interventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily Receives: Drug: HO/02/02 20µg |
| Aloe Vera Jel | Sham comparator | To be applied topically Receives: Other: Aloe Vera Jel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients using HO/02/02 20µg that developed grade 1-4 radiation dermatitis during adjuvant radiation therapy for breast cancer compared to SoC (Aloe Vera) commonly used as standard of care treatment.
Measured: 62 days
Secondary outcomes (1)
Frequency and severity of adverse events reported by the patients and assessed clinically by NCI CTC v2.0
Measured: 62 Days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2013 (estimated)
- Study startSep 2013
- Primary completionSep 2014 (estimated)
- Study completionDec 2014 (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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- HealOr
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Yair Alegranti, Study director, HealOr
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01923220
- Sponsor's protocol ID
- HO-ARD-01-2012
- Acronym
- ARD
- Status last verified
- Aug 2013
- First submitted
- 12 Aug 2013
- Last updated
- 15 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Randomized Study to Evaluate the Safety and Efficacy of HO/02/02 20µg vs. SoC (Aloe Vera) to Reduce Radiation Dermatitis In Breast Cancer Patients Undergoing Radiation Therapy.
- ClinicalTrials.gov ID
- NCT01923220
- Acronym / sponsor ID
- ARD / HO-ARD-01-2012
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Radiation Therapy, Radiation Dermatitis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- HealOrIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Sep 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 15 Aug 2013 (estimated)
- 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.
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment
Detailed description
This is a single-center, open-label, randomized, prospective study evaluating the safety and efficacy of HO/02/02 20µg topically applied daily for 15 minutes (with gauze) on treatment fields vs. standard of care (SoC), Aloe Vera treatment in addition to sterile water for irrigation applied daily for 15 minutes (with gauze) on treatment fields to create the same cooling effect as in treatment arm 1. Both treatment arms 1\&2 treatments will be applied topically once daily for up to 8 weeks to reduce radiation dermatitis in up to 90 breast cancer patients undergoing adjuvant radiation therapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| HO/02/02 | Experimental | Drug: HO/02/02 20µgInterventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily |
| Aloe Vera Jel | Sham comparator | Other: Aloe Vera JelTo be applied topically |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female patients 18 years old and above.
- Histology confirmed unilateral breast cancer following lumpectomy
- Planned to receive 50 Gy, whole breast XRT and regional lymph nodes radiation.
- ECOG performance status 0-2
- Completed Chemotherapy 3 weeks prior to XRT (if applicable)
Key exclusion criteria (12 listed)
- Known uncontrolled diabetes
- Prior radiation to breast
- Known connective tissue disorder
- Known skin disease over the treated breast
- Prior burn over treated area
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 |
|---|---|---|
| HO/02/02 20µgInterventions involving HO/02/02 20µg VS. Aloe Vera Jel (SOC). Treatment will be applied topically once daily | Drug | HO/02/02 |
| Aloe Vera JelTo be applied topically once daily | Other | Aloe Vera Jel |
Primary outcome
Number of patients using HO/02/02 20µg that developed grade 1-4 radiation dermatitis during adjuvant radiation therapy for breast cancer compared to SoC (Aloe Vera) commonly used as standard of care treatment.
Time frame: 62 days
1 secondary outcome
Frequency and severity of adverse events reported by the patients and assessed clinically by NCI CTC v2.0
Time frame: 62 Days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2013.
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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.
Yair Alegranti study director
HealOr
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing HO/02/02 20µg and Aloe Vera Jel in people with Breast Cancer, run by HealOr 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 12 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 15 Aug 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Yair Alegranti (+972-8-9407188 ext. 122, yair@healor.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients using HO/02/02 20µg that developed grade 1-4 radiation dermatitis during adjuvant radiation therapy for breast cancer compared to SoC (Aloe Vera) commonly used as standard of care treatment. (time frame: 62 days). 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 15 Aug 2013.