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Topical Use of Difinsa53™ to Prevent Radiation Dermatitis

NCT ID: NCT02534129

Last Updated: 2017-10-06

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-08-31

Study Completion Date

2016-03-31

Brief Summary

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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

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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.

Conditions

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Radiodermatitis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Single Arm

Radiation field is divided into two sections, one treated with Difinsa53 and the other with Aquaphor

Group Type EXPERIMENTAL

Difinsa53

Intervention Type DRUG

Difinsa53 cream is applied to one half of radiation field

Aquaphor

Intervention Type DRUG

Aquaphor is applied to one half of radiation field

Interventions

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Difinsa53

Difinsa53 cream is applied to one half of radiation field

Intervention Type DRUG

Aquaphor

Aquaphor is applied to one half of radiation field

Intervention Type DRUG

Other Intervention Names

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Dimethicone petrolatum

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Poudre Valley Health System

OTHER

Sponsor Role collaborator

ProTechSure Scientific, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joshua Petit, MD

Role: PRINCIPAL_INVESTIGATOR

UC Health, Poudre Valley Hospital

Locations

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Poudre Valley Health System

Fort Collins, Colorado, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 21514477 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21786113 (View on PubMed)

Other Identifiers

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ProTechSure 001

Identifier Type: -

Identifier Source: org_study_id