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.
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Full eligibility criteria for NCT01597921
Ages eligible for Study
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
All locations for NCT01597921
Sheba Medical Center
Ramat-Gan, Israel, 55555
View full eligibility
Tris trial is registered with FDA with number: NCT01597921. The sponsor of the trial is Water-Jel and it is looking for 50 volunteers for the current phase.
Official trial 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
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