Topical Keratin in Treating Radiation Dermatitis in Patients With Breast Cancer

NCT03374995 | Completed Results FDA Device

• 4 other identifiers: IRB00046759NCI-2017-02011CCCWFU 97417P30CA012197
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Carcinoma; Radiation-Induced Dermatitis

Outcome Measures

Primary Outcomes (4)

• Incidence of Early Adverse Skin Reactions (EASRs)

  The Modified ONS Criteria for Radiation-Induced Acute Skin Toxicity will be used for classification of EASRs related to the skin. Participants will report in a total of 7 visits any experience with Grade I (faint or dull erythema; dry desquamation or Grade II (tender or bright erythema, patchy, moist desquamation) acute radiation dermatitis using the RTOG (Radiation Therapy Oncology Group) grading system with Grade II considered the worse outcome. Comparative effectiveness will include the number or study participants in each arm that experience RTOG Grade I or Grade II radiation dermatitis and moist desquamation.

  Up to 4 weeks post-RT

• Change in Quality of Life

  A 10-item assessment completed at each visit (7 total) to measure participant's Dermatology Life Quality Index. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. The higher the score the more qualify of life is impaired. The average DQLI score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.

  Baseline to up to 7 weeks

• Physician Observed Improvement in Skin Appearance

  Skin appearance was assessed by the treating physician at each visit (total of 7) using the Radiation Therapy Oncology Group (RTOG) Toxicity scale Grade 1 and Grade 2 assessed only. Score = (Grade 1 (follicular, faint or dull erythema, dry desquamation and Grade 2 (tender or bright erythema, patchy, ,moist desquamation) with Grade 2 being the worst for this study. Scores range from 0 to 2, with higher values being the worst. The average RTOG score at each study visit will be compared between the KeraStat® Cream arm and the SOC arm as a study effectiveness measure.

  Baseline to up to 7 weeks

• Number of Participants Reported Change in Skin Appearance Using the Dermatology Quality of Life Index Scale

  Change in skin appearance by the participants' self-report using the Dermatology Quality of Life Index (DLQI) was used to assess skin after completion of radiation. Score range is 0-3 (very much = 3; a lot = 2; a little = 1; and not at all or not relevant = 0) Maximum score of 30. A higher score shows better performance/improvement in skin appearance. The average Dermatology Qualify of Life Index score each study visit will be compared between the two arms with the number of participants reporting a score.

  Baseline to up to 7 weeks

Study Arms (2)

Group I (topical keratin)

EXPERIMENTAL

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

Other: Quality-of-Life Assessment; Device: Topical Keratin

Group II (standard of care)

ACTIVE COMPARATOR

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

Other: Best Practice; Other: Quality-of-Life Assessment

Interventions

Best Practice OTHER

Receive standard of care

Also known as: standard of care, standard therapy

Group II (standard of care)

Quality-of-Life Assessment OTHER

Ancillary studies

Also known as: Quality of Life Assessment

Group I (topical keratin); Group II (standard of care)

Topical Keratin DEVICE

Given topically

Also known as: KeraStat

Group I (topical keratin)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Radiodermatitis

Interventions

Practice Guidelines as Topic; Standard of Care

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Dermatitis; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Guidelines as Topic; Quality Assurance, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality Indicators, Health Care

Results Point of Contact

• Title: Principal investigator
• Organization: Wake Forest University Health Sciences

kwinkfie@wakehealth.edu

336-716-5440

Study Officials

• Karen Winkfield

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 15, 2017
• Study Start: March 26, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 11, 2024
• Results First Posted: February 12, 2020

Record last verified: 2020-02

Locations

US (1)