Breast CancerNCT01597921
A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
An observational study of Breast Cancer and Radiation Dermatitis, run by Water-Jel at 1 site in Israel.
Trial summary
The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy. Read more about this study
- Who is it for?
- Any age, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Radiation Dermatitis, Erythema
- How many people
- 50 participants
- Where
- 1 siteIsrael
- Study dates
- May 2012to Dec 2012
- Phase
- Observational
- 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 Any age
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: 75
Who may be able to join
- Woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 Gy/fx to a total dose of 50 Gy.
- Women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. Three weeks is the minimal interval between chemotherapy and start of radiation therapy.
- Patient able to understand the study designed and cooperate with instructions of use.
- Patient able to sign informed consent
Who cannot join
- Woman with lactose allergy (lactose intolerance are eligible)
- Woman with known connective tissue disorder
- Woman with uncontrolled diabetes
- Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx
- Woman who is unable to sign an informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase II, Double Blinded, Randomized Study of R1 and R2 (Waterjel) Verses Aloe Vera Jell for the Prevention and Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.
Read the detailed description
All women will be given two types of Jell. One should be applied immediately after radiation and the second one, 3 times every day. All women will complete detailed questionnaire every two weeks and will be evaluated by the treating team at the same time.All women will be evaluated two weeks after end of radiation period.
- Conditions
- Breast Cancer, Radiation Dermatitis, Erythema
- Keywords
- Breast conserving surgery, Radiation dermatitis
- Medical subject headings
- Breast Neoplasms, Radiodermatitis, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Breast cancer patient receiving RT | Total dose:2Gy/Fx |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: The study was stopped due to unbalanced side effects
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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Water-Jel
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Dr Merav Ben-David, Water-Jel
- Investigators
- Merav Ben David, Principal investigator, La Sheba Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01597921
- Sponsor's protocol ID
- 23267384
- Status last verified
- Aug 2012
- First submitted
- 10 May 2012
- Last updated
- 9 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase II, Double Blinded, Randomized Study of R1 and R2 (Waterjel) Verses Aloe Vera Jell for the Prevention and Treatment of Radiation Induced Dermatitis in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT01597921
- Acronym / sponsor ID
- 23267384
- Conditions
- Breast Cancer, Radiation Dermatitis, Erythema
- Keywords
- Breast conserving surgery, Radiation dermatitis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was stopped due to unbalanced side effects
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Water-JelIndustry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 14 May 2012 (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.
The purpose of this study is to evaluate the effects of topical R1 and R2 for prophylaxis of acute radiation dermatitis in patients with breast cancer receiving radiotherapy.
Detailed description
All women will be given two types of Jell. One should be applied immediately after radiation and the second one, 3 times every day. All women will complete detailed questionnaire every two weeks and will be evaluated by the treating team at the same time.All women will be evaluated two weeks after end of radiation period.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast cancer patient receiving RT | – | –Total dose:2Gy/Fx |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- 75
Key inclusion criteria (4 listed)
- Woman with histologically confirmed breast cancer who underwent lumpectomy and requires adjuvant radiation therapy with 2 Gy/fx to a total dose of 50 Gy.
- Women who received neoadjuvant or adjuvant chemotherapy are eligible for the study. Three weeks is the minimal interval between chemotherapy and start of radiation therapy.
- Patient able to understand the study designed and cooperate with instructions of use.
- Patient able to sign informed consent
Key exclusion criteria (5 listed)
- Woman with lactose allergy (lactose intolerance are eligible)
- Woman with known connective tissue disorder
- Woman with uncontrolled diabetes
- Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx
- Woman who is unable to sign an informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study was stopped early (reason given: The study was stopped due to unbalanced side effects). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2012.
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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.
Merav Ben David principal investigator
La Sheba Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Radiation Dermatitis, run by Water-Jel 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 4 inclusion and 5 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: stopped early, as of the sponsor's last update on 9 Aug 2012. 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?
The study was stopped early (reason given: The study was stopped due to unbalanced side effects). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
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 9 Aug 2012; AzTrials last refreshed its copy on 7 Nov 2026.