Clinical trial NCT03374995: Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer
Official title: Pilot Study: KeraStat Cream for Radiation Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Carcinoma
Radiation-Induced Dermatitis
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2017-12-15
Enrollment: 25
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: This randomized pilot clinical trial studies how well topical keratin works in treating radiation dermatitis in patients with breast cancer. Radiation dermatitis is a skin condition that is a common side effect of radiation therapy. The affected skin becomes painful, red, itchy, and blistered. Topical keratin may help to improve skin appearance and hydration in patients with breast cancer.

Detailed description: PRIMARY OBJECTIVES:

I. To determine a preliminary estimate of the improvement of skin's natural barrier, decrease of dehydration, and reduction in the appearance of inflammation associated with radiation therapy (RT) skin toxicity as well as patients' satisfaction with their skin after the application of the medical device topical keratin (KeraStat Cream) during RT in breast cancer patients.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients receive topical keratin topically at least twice daily (BID) until the end of radiation therapy (approximately 3-6 weeks).

GROUP II: Patients receive standard of care as directed by radiation oncologist until the end of radiation therapy (approximately 3-6 weeks).

After completion of study treatment, patients are followed up at 4-6 weeks.

Eligibility criteria: Inclusion Criteria:

* Diagnosis of breast cancer, received chemotherapy, and scheduled to receive 4 to 6 weeks of radiation therapy (radiation protocol of 42 Gy+)
* Area to be irradiated representing 1-10% of total body surface area (TBSA)
* Able and willing to sign protocol consent form
* Able and willing to document symptoms and treatment details as often as needed, not to exceed daily notes
* Able and willing to have photographs of the affected area taken regularly

Exclusion Criteria:

* Women who are pregnant, lactating/nursing or plan to become pregnant
* Previous radiation therapy to the area to be treated with radiation therapy
* Receiving palliative radiation therapy
* Unhealed or infected surgical sites in the irradiation area
* Patients undergoing cytotoxic chemotherapy or concurrent Herceptin as part of overall treatment plan (tamoxifen/aromatase inhibitor allowed)
* Use of oral corticosteroids or topical corticosteroids in the irradiation area
* Use of Erbitux
* Autoimmune disease
* Skin disease in target irradiation area
* Smoker
* Known allergy to the standard of care or ingredients in KeraStat Cream

Primary outcomes:
measure: Incidence of Early Adverse Skin Reactions (EASRs)
timeFrame: Up to 4 weeks post-RT
measure: Change in Quality of Life
timeFrame: Baseline to up to 7 weeks
measure: Physician Observed Improvement in Skin Appearance
timeFrame: Baseline to up to 7 weeks
measure: Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale
timeFrame: Baseline to up to 7 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Comprehensive Cancer Center of Wake Forest University
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Karen Winkfield
role: PRINCIPAL_INVESTIGATOR
References: