## Protocol Section
### Identification Module
**NCT ID:** NCT02168179

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

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

#### Organization Study ID Info
**ID:** IRB00028009
#### Organization
**Class:** OTHER
**Full Name:** Wake Forest University Health Sciences
#### Secondary ID Infos
**Domain:** CTRP (Clinical Trial Reporting Program)
**ID:** NCI-2014-01274
**Type:** REGISTRY
**ID:** CCCWFU 98114
**ID:** P30CA012197
**Link:** https://reporter.nih.gov/quickSearch/P30CA012197
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2016-07

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2018-07-05

**Type:** ACTUAL

**Last Update Submit Date:** 2018-07-02

**Overall Status:** WITHDRAWN

#### Primary Completion Date
**Date:** 2016-07

**Type:** ACTUAL

#### Start Date
**Date:** 2014-12

**Type:** ACTUAL

**Status Verified Date:** 2018-07

#### Study First Post Date
**Date:** 2014-06-20
**Type:** ESTIMATED
**Study First Submit Date:** 2014-06-18
**Study First Submit QC Date:** 2014-06-18
**Why Stopped:** No longer pursuing study at our site.
### Sponsor Collaborators Module

#### Collaborators

**Class:** NIH

**Name:** National Cancer Institute (NCI)

#### Lead Sponsor

**Class:** OTHER

**Name:** Wake Forest University Health Sciences

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** False

### Description Module

**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.

### Conditions Module

**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

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** SUPPORTIVE_CARE

#### Enrollment Info

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Patients apply KeraStat Skin Therapy topically BID during radiation therapy.

**Intervention Names:**

- Procedure: dermatologic complications management/prevention

- Other: questionnaire administration

**Label:** Supportive Care (KeraStat Skin Therapy)

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Supportive Care (KeraStat Skin Therapy)

**Description:** Apply KeraStat Skin Therapy topically

**Name:** dermatologic complications management/prevention

**Other Names:**

- complications management/prevention, dermatologic

- management/prevention, dermatologic complications

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- Supportive Care (KeraStat Skin Therapy)

**Description:** Ancillary studies

**Name:** questionnaire administration

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** A series of 2xr tables will be examined to determine the relationship between each of the categorical confounders and the primary endpoint. Chi-squared statistics will be estimated for each of these tables to give some preliminary descriptive data to identify potential variables that may be associated with the primary outcome.

**Measure:** Categorical confounders, such as race/ethnicity, age, hormone therapy, smoking history/status, diabetes, high blood pressure, breast size, RT characteristics, and RT dosimetry characteristics, using the Baseline Study Risk Questionnaire

**Time Frame:** Baseline

#### Primary Outcomes

**Description:** 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.

**Measure:** 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

**Time Frame:** Up to 2 months after completion of radiation therapy

### Eligibility Module

**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

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Winston-Salem

**Country:** United States

**Facility:** Comprehensive Cancer Center of Wake Forest University

**State:** North Carolina

**Zip:** 27157

#### Overall Officials

**Official 1:**

**Affiliation:** Wake Forest University Health Sciences

**Name:** Arthur Blackstock

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000009371

- Term: Neoplasms by Site

- ID: D000009369

- Term: Neoplasms

- ID: D000001941

- Term: Breast Diseases

- ID: D000012871

- Term: Skin Diseases

- ID: D000002277

- Term: Carcinoma

- ID: D000009375

- Term: Neoplasms, Glandular and Epithelial

- ID: D000009370

- Term: Neoplasms by Histologic Type

- ID: D000044584

- Term: Carcinoma, Ductal

- ID: D000000230

- Term: Adenocarcinoma

- ID: D000018299

- Term: Neoplasms, Ductal, Lobular, and Medullary

- ID: D000011832

- Term: Radiation Injuries

- ID: D000014947

- Term: Wounds and Injuries

### Condition Browse Module - Browse Branches

- Abbrev: BC04

- Name: Neoplasms

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BC26

- Name: Wounds and Injuries

### Condition Browse Module - Browse Leaves

- ID: M5220

- Name: Breast Neoplasms

- Relevance: HIGH

- As Found: Breast Cancer

- ID: M5534

- Name: Carcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M7067

- Name: Dermatitis

- Relevance: HIGH

- As Found: Dermatitis

- ID: M12307

- Name: Neoplasm Metastasis

- Relevance: LOW

- As Found: Unknown

- ID: M5535

- Name: Carcinoma in Situ

- Relevance: HIGH

- As Found: Carcinoma in Situ

- ID: M895

- Name: Breast Carcinoma In Situ

- Relevance: HIGH

- As Found: Breast carcinoma in situ

- ID: M5542

- Name: Carcinoma, Intraductal, Noninfiltrating

- Relevance: HIGH

- As Found: Ductal breast carcinoma in situ

- ID: M20415

- Name: Carcinoma, Ductal, Breast

- Relevance: HIGH

- As Found: Ductal breast carcinoma

- ID: M14701

- Name: Radiodermatitis

- Relevance: HIGH

- As Found: Radiation Dermatitis

- ID: M25356

- Name: Carcinoma, Ductal

- Relevance: LOW

- As Found: Unknown

- ID: M5218

- Name: Breast Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M12320

- Name: Neoplasms, Glandular and Epithelial

- Relevance: LOW

- As Found: Unknown

- ID: M12315

- Name: Neoplasms by Histologic Type

- Relevance: LOW

- As Found: Unknown

- ID: M3585

- Name: Adenocarcinoma

- Relevance: LOW

- As Found: Unknown

- ID: M14679

- Name: Radiation Injuries

- Relevance: LOW

- As Found: Unknown

- ID: M17685

- Name: Wounds and Injuries

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000001943

- Term: Breast Neoplasms

- ID: D000002278

- Term: Carcinoma in Situ

- ID: D000018270

- Term: Carcinoma, Ductal, Breast

- ID: D000071960

- Term: Breast Carcinoma In Situ

- ID: D000002285

- Term: Carcinoma, Intraductal, Noninfiltrating

- ID: D000003872

- Term: Dermatitis

- ID: D000011855

- Term: Radiodermatitis

### Misc Info Module

- Version Holder: 2024-05-24
