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

May 10, 2012
August 8, 2012
May 2012
December 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01597921 on ClinicalTrials.gov Archive Site
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A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer
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

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Probability Sample

75

  • Breast Cancer
  • Radiation Dermatitis
  • Erythema
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Breast cancer patient receiving RT
Total dose:2Gy/Fx
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
December 2012
December 2012   (final data collection date for primary outcome measure)

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
Female
Not Provided
Yes
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01597921
23267384
No
Dr Merav Ben-David, Water-Jel
Water-Jel
Not Provided
Principal Investigator: Merav Ben David La Sheba Hospital
Water-Jel
August 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP