Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-26

Study Completion Date

2018-11-01

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Breast Carcinoma Radiation-Induced Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Group I (topical keratin)

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

Group Type EXPERIMENTAL

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Topical Keratin

Intervention Type DEVICE

Given topically

Group II (standard of care)

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

Group Type ACTIVE_COMPARATOR

Best Practice

Intervention Type OTHER

Receive standard of care

Quality-of-Life Assessment

Intervention Type OTHER

Ancillary studies

Interventions

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Best Practice

Receive standard of care

Intervention Type OTHER

Quality-of-Life Assessment

Ancillary studies

Intervention Type OTHER

Topical Keratin

Given topically

Intervention Type DEVICE

Other Intervention Names

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standard of care standard therapy Quality of Life Assessment KeraStat

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No