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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01597921

Enrollment

Registered

2012-05-14

Start date

2012-05-31

Completion date

2012-12-31

Last updated

2012-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Erythema, Radiation Dermatitis

Keywords

Breast conserving surgery, Radiation dermatitis

Brief summary

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.

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

Yes

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

Countries

Israel

Outcome results