Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

Radiodermatitis Clinical Trial

Official title:

Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02534129
• Other study ID #: ProTechSure 001
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: August 19, 2015
• Last updated: October 4, 2017
• Start date: August 2015
• Est. completion date: March 2016

Study information

• Verified date: October 2017
• Source: ProTechSure Scientific, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Phase II trial of the silibin containing cream, Difinsa53 to determine efficacy in delaying, ameliorating, or preventing radiation dermatitis in patients with breast cancer undergoing whole breast radiation.

Description:

The proposed study seeks to evaluate the efficacy of DIFINISA53™, a safe silibin-based skin cream, on preventing radiation dermatitis (RD) when compared to an over the counter ointment, Aquaphor, in women undergoing radiation therapy for breast cancer following lumpectomy or mastectomy surgery. Presently there is no known fully effective topical protectant from RD and there is no consensus among radiation oncologists on how best to treat RD. This study seeks to identify a more effective option for patients receiving radiation therapy. Each participant will apply the DIFINISA53™ cream to one area of the treated skin and Aquaphor to another area of treated skin. Skin reactions will be evaluated using medical professional assessment, participant assessment, and photographic assessment by a third party.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 13
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Female patients 18 years and older

• Pathologic diagnosis of breast cancer requiring radiation therapy to whole breast

• Able to apply lotion to treatment area at least twice daily during radiation course

• All surgical sites healed

• No evidence of infection

• No history of sensitivity to any component in Aquaphor or Difensa53

Exclusion Criteria:

• Prior history of radiation therapy (RT) to that site

• Known dermatologic conditions affecting skin in radiation port

• Concurrent chemotherapy

• Skin infection in radiation port

• History of sensitivity to Aquaphor or Difensa53 component

Related Conditions & MeSH terms

• Dermatitis
• Radiodermatitis

Intervention

Drug:
• Difinsa53
Difinsa53 cream is applied to one half of radiation field
• Aquaphor
Aquaphor is applied to one half of radiation field

Locations

Country	Name	City	State
United States	Poudre Valley Health System	Fort Collins	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
ProTechSure Scientific, Inc.	Poudre Valley Health System

Country where clinical trial is conducted

United States, 

References & Publications (2)

Becker-Schiebe M, Mengs U, Schaefer M, Bulitta M, Hoffmann W. Topical use of a silymarin-based preparation to prevent radiodermatitis : results of a prospective study in breast cancer patients. Strahlenther Onkol. 2011 Aug;187(8):485-91. doi: 10.1007/s00066-011-2204-z. Epub 2011 Jul 22. — View Citation

McQuestion M. Evidence-based skin care management in radiation therapy: clinical update. Semin Oncol Nurs. 2011 May;27(2):e1-17. doi: 10.1016/j.soncn.2011.02.009. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria	A blinded observer will quantify degree of dermatitis assigning each half of the radiation field a score from 0 to 4. 0 represents no dermatitis and 4 is severe dermatitis using the RTOG scoring criteria.	8 weeks