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

Wake Forest University (WFU)

Status

Withdrawn

Conditions

Stage IIIA Breast Cancer

Stage IB Breast Cancer

Stage IIB Breast Cancer

Stage IIA Breast Cancer

Stage IA Breast Cancer

Skin Reactions Secondary to Radiation Therapy

Ductal Breast Carcinoma in Situ

Treatments

Other: questionnaire administration

Procedure: dermatologic complications management/prevention

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT02168179

CCCWFU 98114

P30CA012197 (U.S. NIH Grant/Contract)

IRB00028009

NCI-2014-01274 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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