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NCT01597921 Clinical Trial

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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT01597921
Other study ID # 23267384
Secondary ID
Status Terminated
Phase N/A
First received May 10, 2012
Last updated August 8, 2012
Start date May 2012
Est. completion date December 2012

Study information
Verified date August 2012
Source Water-Jel
Contact n/a
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Observational

Clinical 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.

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.

Recruitment information / eligibility
Status Terminated
Enrollment 50
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba Medical Center Ramat-Gan

Sponsors (1)
Lead Sponsor Collaborator
Water-Jel

Country where clinical trial is conducted

Israel, 

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