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

Last updated: July 2, 2018
Sponsor: Wake Forest University Health Sciences
Overall Status: Trial Not Available

Phase

N/A

Condition

Breast Cancer

Allergy

Precancerous Condition

Treatment

N/A

Clinical Study ID

NCT02168179
IRB00028009
CCCWFU 98114
NCI-2014-01274
P30CA012197
  • Ages > 18
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Newly diagnosed with breast carcinoma, stage 0-IIIA (including ductal carcinoma insitu [DCIS])

  • Status post-lumpectomy, -quadrantectomy, or -mastectomy

  • Plan to receive adjuvant radiation to the whole breast or chest wall +/- regionallymph nodes

  • Total dose >= 40Gy

  • Dose per fraction >= 1.8 use of 2-dimensional (2D), 3-dimensional (3D) conformal, orintensity-modulated radiation therapy (IMRT) treatment techniques allowed; skinsparing IMRT patients excluded; a daily fraction of 2.7 Gy to the whole breast issuggested for hypofractionated regimens

  • Concurrent and sequential boost techniques are allowed for both standard andhypofractionated regimens

  • Adjuvant hormonal therapy will be allowed prior to, during and/or after RT at thediscretion of a medical oncologist

  • Targeted therapies such as Herceptin will be allowed prior to, during, and/or after RTat the discretion of the medical oncologist

  • Patients who are able and willing to sign protocol consent form

Exclusion

Exclusion Criteria:

  • Prior radiation to the involved breast or chest wall

  • Concurrent chemotherapy; (patients may receive chemotherapy prior to radiation orfollowing radiation at the treating physician's discretion)

  • Patients who underwent breast reconstruction following mastectomy (placement of tissueexpanders 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 theskin ie: applying lotions /moisturizers; protocols that do not involve treatment ofthe skin are allowed

  • Patients who are pregnant or breastfeeding

Study Design

Study Start date:
December 01, 2014
Estimated Completion Date:
July 31, 2016

Study 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.

Connect with a study center

  • Comprehensive Cancer Center of Wake Forest University

    Winston-Salem, North Carolina 27157
    United States

    Site Not Available

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