NCT02534129

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_1

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

August 19, 2015

Completed
8 days until next milestone

First Posted

Study publicly available on registry

August 27, 2015

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

October 6, 2017

Completed
Last Updated

October 6, 2017

Status Verified

October 1, 2017

Enrollment Period

7 months

First QC Date

August 19, 2015

Results QC Date

April 6, 2017

Last Update Submit

October 4, 2017

Conditions

Radiodermatitis

Keywords

breast cancerradiationdermatitis

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Single Arm

EXPERIMENTAL

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

Drug: Difinsa53Drug: Aquaphor

Interventions

Difinsa53DRUG

Difinsa53 cream is applied to one half of radiation field

Also known as: Dimethicone
Single Arm
AquaphorDRUG

Aquaphor is applied to one half of radiation field

Also known as: petrolatum
Single Arm

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Poudre Valley Health System

Fort Collins, Colorado, 80528, United States

Location

Related Publications (2)

  • 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.

    PMID: 21514477BACKGROUND

  • 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.

    PMID: 21786113BACKGROUND

MeSH Terms

Conditions

RadiodermatitisBreast NeoplasmsDermatitis

Interventions

dimethiconePetrolatum

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesRadiation InjuriesWounds and InjuriesNeoplasms by SiteNeoplasmsBreast Diseases

Intervention Hierarchy (Ancestors)

HydrocarbonsOrganic Chemicals

Limitations and Caveats

This trial was terminated early, based on minimal radiation dermatitis (scores of 0-1 only in most fields evaluated) that precluded any meaningful analysis of any differing effect in the two treatment arms.

Results Point of Contact

Title
L. Michael Glode, MD
Organization
ProTechSure Scientific Inc.
mike.glode@ucdenver.edu
303-526-9031

Study Officials

  • Joshua Petit, MD

    UC Health, Poudre Valley Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 19, 2015

First Posted

August 27, 2015

Study Start

August 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

October 6, 2017

Results First Posted

October 6, 2017

Record last verified: 2017-10

Locations

US(1)