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

Terminated

• Conditions: Breast Cancer; Radiation Dermatitis; Erythema

• Registration Number: NCT01597921
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-10
• Study First Submitted QC: 2012-05-11
• Study First Posted: 2012-05-14
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-08
• Last Update Posted: 2012-08-09
• Primary Completion: 2012-12
• Study Completion: 2012-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Sheba Medical Center; 🇮🇱 Ramat-Gan, Israel