Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

Wake Forest University (WFU)

Status: Completed

Conditions: Radiation-Induced Dermatitis; Breast Carcinoma

Treatments: Other: Best Practice; Device: Topical Keratin; Other: Quality-of-Life Assessment

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03374995

P30CA012197 (U.S. NIH Grant/Contract)

IRB00046759

NCI-2017-02011 (Registry Identifier)

CCCWFU 97417 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 25 patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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25 participants in 2 patient groups

Group I (topical keratin)

Experimental group

Description:

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

Treatment:

Other: Quality-of-Life Assessment

Device: Topical Keratin

Group II (standard of care)

Active Comparator group

Description:

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

Treatment:

Other: Quality-of-Life Assessment

Other: Best Practice