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

NCT ID: NCT02168179

Last Updated: 2018-07-05

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-07-31

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

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Supportive Care (KeraStat Skin Therapy)

Patients apply KeraStat Skin Therapy topically BID during radiation therapy.

Group Type: EXPERIMENTAL

dermatologic complications management/prevention

Intervention Type: PROCEDURE

Apply KeraStat Skin Therapy topically

questionnaire administration

Intervention Type: OTHER

Ancillary studies

Interventions

dermatologic complications management/prevention

Apply KeraStat Skin Therapy topically

Intervention Type: PROCEDURE

questionnaire administration

Ancillary studies

Intervention Type: OTHER

Other Intervention Names

complications management/prevention, dermatologic; management/prevention, dermatologic complications

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 Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arthur Blackstock

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Countries

United States

Other Identifiers

NCI-2014-01274

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 98114

Identifier Type: -

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00028009

Identifier Type: -

Identifier Source: org_study_id