A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01597921
Recruitment Status : Terminated (The study was stopped due to unbalanced side effects)
First Posted : May 14, 2012
Last Update Posted : August 9, 2012
Information provided by (Responsible Party):
Dr Merav Ben-David, Water-Jel

Brief 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.

Condition or disease
Breast Cancer Radiation Dermatitis Erythema

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
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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
Study Start Date : May 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Breast cancer patient receiving RT
Total dose:2Gy/Fx

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Inclusion Criteria:

  1. 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.
  2. 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.
  3. Patient able to understand the study designed and cooperate with instructions of use.
  4. Patient able to sign informed consent

Exclusion Criteria:

  1. Woman with lactose allergy (lactose intolerance are eligible)
  2. Woman with known connective tissue disorder
  3. Woman with uncontrolled diabetes
  4. Patients receiving radiation protocol with 2.64 Gy/fx or 1.8 Gy/fx
  5. Woman who is unable to sign an informed consent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01597921

Sheba Medical Center
Ramat-Gan, Israel, 55555
Sponsors and Collaborators
Principal Investigator: Merav Ben David La Sheba Hospital

Responsible Party: Dr Merav Ben-David, Dr, Water-Jel Identifier: NCT01597921     History of Changes
Other Study ID Numbers: 23267384
First Posted: May 14, 2012    Key Record Dates
Last Update Posted: August 9, 2012
Last Verified: August 2012

Keywords provided by Dr Merav Ben-David, Water-Jel:
Breast conserving surgery
Radiation dermatitis

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Radiation Injuries
Wounds and Injuries