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

Withdrawn before enrolling · Not applicable

Conditions studied: 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

In brief

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.

Key facts

Study ID

NCT02168179

Run by

Wake Forest University Health Sciences

People needed

0

Starts

2014-12-01

Expected to finish

2016-07-01

Last updated by the study team

2018-07-05

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Comprehensive Cancer Center of Wake Forest University — Winston-Salem, North Carolina, United States

Full record on ClinicalTrials.gov

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