Clinical trial NCT02534129: Topical Use of Difinsa53™ to Prevent Radiation Dermatitis
Official title: Topical Use of a Silibin-based Cream, Difinsa53™, to Prevent Radiation Dermatitis in Patients With Breast Cancer: A Prospective Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Radiodermatitis
Keywords: breast cancer
radiation
dermatitis
Lead sponsor: ProTechSure Scientific, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Poudre Valley Health System
First posted: 2015-08-27
Enrollment: 13
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Radiation Dermatitis as Determined by Radiation Therapy Oncology Group (RTOG) Acute Radiation Morbidity Scoring Criteria
timeFrame: 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Fort Collins
country: United States
facility: Poudre Valley Health System
state: Colorado
Study officials:
affiliation: UC Health, Poudre Valley Hospital
name: Joshua Petit, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.