KeraStat Skin Therapy in Treating Radiation Dermatitis in Patients With Newly Diagnosed Stage 0-IIIA Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This pilot clinical trial studies KeraStat Skin Therapy in treating radiation dermatitis in patients with newly diagnosed stage 0-IIIA breast cancer. Radiation dermatitis is an itchy, painful skin rash that can occur following treatment with radiation. KeraStat Skin Therapy may be a better treatment for radiation dermatitis.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. To obtain a preliminary estimate the incidence of early adverse skin reaction (EASR) during radiation therapy (RT) and up to two months post RT after the application of the cosmetic cream KeraStat Skin Therapy during RT in breast cancer patients in a pilot study. SECONDARY OBJECTIVES: I. To associate personal characteristics (e.g., race/ethnicity, age, hormone therapy, smoking status, comorbidities, breast size) and treatment characteristics (e.g., RT dose) to incidence of EASR at any time point. OUTLINE: Patients apply KeraStat Skin Therapy topically twice daily (BID) during radiation therapy. After completion of study treatment, patients are followed up at 1 and 2 months.

Official Title
-----------------
Safety of Treatment With KeraStat Skin Therapy in Breast Cancer Patients Developing Radiation Dermatitis

Conditions
-----------------
Ductal Breast Carcinoma in Situ, Skin Reactions Secondary to Radiation Therapy, Stage IA Breast Cancer, Stage IB Breast Cancer, Stage IIA Breast Cancer, Stage IIB Breast Cancer, Stage IIIA Breast Cancer

Intervention / Treatment
-----------------
* Procedure: dermatologic complications management/prevention
* Other: questionnaire administration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed with breast carcinoma, stage 0-IIIA (including ductal carcinoma in situ [DCIS]) Status post-lumpectomy, -quadrantectomy, or -mastectomy Plan to receive adjuvant radiation to the whole breast or chest wall +/- regional lymph nodes Total dose >= 40Gy Dose per fraction >= 1.8 use of 2-dimensional (2D), 3-dimensional (3D) conformal, or intensity-modulated radiation therapy (IMRT) treatment techniques allowed; skin sparing IMRT patients excluded; a daily fraction of 2.7 Gy to the whole breast is suggested for hypofractionated regimens Concurrent and sequential boost techniques are allowed for both standard and hypofractionated regimens Adjuvant hormonal therapy will be allowed prior to, during and/or after RT at the discretion of a medical oncologist Targeted therapies such as Herceptin will be allowed prior to, during, and/or after RT at the discretion of the medical oncologist Patients who are able and willing to sign protocol consent form Exclusion Criteria: Prior radiation to the involved breast or chest wall Concurrent chemotherapy; (patients may receive chemotherapy prior to radiation or following radiation at the treating physician's discretion) Patients who underwent breast reconstruction following mastectomy (placement of tissue expanders and implants are not allowed) Patients undergoing partial breast irradiation Patients who have undergone MammoSite® or any other form of brachytherapy Patients may not be concurrently enrolled in a protocol that involves treatment of the skin ie: applying lotions /moisturizers; protocols that do not involve treatment of the skin are allowed Patients who are pregnant or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supportive Care (KeraStat Skin Therapy)<br>Patients apply KeraStat Skin Therapy topically BID during radiation therapy. | Procedure: dermatologic complications management/prevention<br>* Apply KeraStat Skin Therapy topically<br>* Other names: management/prevention, dermatologic complications;Other: questionnaire administration<br>* Ancillary studies<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of any RT-induced EASR defined as a grade 4 or higher toxicity using the Modified Oncology Nursing Society Criteria for Radiation-Induced Acute Skin Toxicity | At each time point the proportion of women who have RT-induced EASR present will be estimated and a 95% confidence interval will be calculated around this estimate. | Up to 2 months after completion of radiation therapy |