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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


N/A
N/A
N/A
Not Enrolling
Female
Breast Cancer, Radiation Dermatitis, Erythema

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Principal Investigator

Merav Ben David

Investigator Role:

Principal Investigator

Investigator Affiliation:

La Sheba Hospital

Authority:

Israel: Ethics Commission

Study ID:

23267384

NCT ID:

NCT01597921

Start Date:

May 2012

Completion Date:

December 2012

Related Keywords:

  • Breast Cancer
  • Radiation Dermatitis
  • Erythema
  • Breast conserving surgery
  • Radiation dermatitis
  • Breast Neoplasms
  • Dermatitis
  • Radiodermatitis
  • Erythema

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