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
• 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

• Breast Cancer
• Breast Neoplasms
• Dermatitis
• Eczema
• Erythema
• Radiation Dermatitis
• Radiodermatitis

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,