A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
This study has been terminated.
(The study was stopped due to unbalanced side effects)
Information provided by (Responsible Party):
Dr Merav Ben-David, Water-Jel
First received: May 10, 2012
Last updated: August 8, 2012
Last verified: August 2012
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.
||Observational Model: Cohort
Time Perspective: Cross-Sectional
||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:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
Breast cancer patient receiving RT
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.
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597921
|Sheba Medical Center
|Ramat-Gan, Israel, 55555 |
||Merav Ben David
||La Sheba Hospital
No publications provided
||Dr Merav Ben-David, Dr, Water-Jel
History of Changes
|Other Study ID Numbers:
|Study First Received:
||May 10, 2012
||August 8, 2012
||Israel: Ethics Commission
Keywords provided by Water-Jel:
Breast conserving surgery
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on September 18, 2014
Neoplasms by Site
Wounds and Injuries