A DB Randomized Study of R1 and R2 WaterJel / AloeVera Jell in Prevention of Radiation Dermatitis in Breast Cancer

Water-Jel

Status: Terminated

Conditions: Breast Cancer; Erythema; Radiation Dermatitis

Study type: Observational

Funder types: Industry

Identifiers

NCT01597921

23267384

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Breast cancer patient receiving RT

Description:

Total dose:2Gy/Fx