- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01597921
A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
August 8, 2012 updated by: Dr Merav Ben-David, Water-Jel
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.
Study Overview
Status
Terminated
Conditions
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 Type
Observational
Enrollment (Actual)
50
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ramat-Gan, Israel, 55555
- Sheba Medical Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Female
Sampling Method
Probability Sample
Study Population
75
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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Breast cancer patient receiving RT
Total dose:2Gy/Fx
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Merav Ben David, La Sheba Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2012
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
May 10, 2012
First Submitted That Met QC Criteria
May 11, 2012
First Posted (Estimate)
May 14, 2012
Study Record Updates
Last Update Posted (Estimate)
August 9, 2012
Last Update Submitted That Met QC Criteria
August 8, 2012
Last Verified
August 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 23267384
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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