Text Size

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)
Sponsor:
Information provided by (Responsible Party):
Dr Merav Ben-David, Water-Jel
ClinicalTrials.gov Identifier:
NCT01597921
First received: May 10, 2012
Last updated: August 8, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Breast Cancer
Radiation Dermatitis
Erythema

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Water-Jel:

Enrollment: 50
Study Start Date: May 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Breast cancer patient receiving RT
Total dose:2Gy/Fx

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

75

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01597921

Locations
Israel
Sheba Medical Center
Ramat-Gan, Israel, 55555
Sponsors and Collaborators
Water-Jel
Investigators
Principal Investigator: Merav Ben David La Sheba Hospital
  More Information

No publications provided

Responsible Party: Dr Merav Ben-David, Dr, Water-Jel
ClinicalTrials.gov Identifier: NCT01597921     History of Changes
Other Study ID Numbers: 23267384
Study First Received: May 10, 2012
Last Updated: August 8, 2012
Health Authority: Israel: Ethics Commission

Keywords provided by Water-Jel:
Breast conserving surgery
Radiation dermatitis

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

ClinicalTrials.gov processed this record on May 19, 2013