Back to resultsPhysioTouch for Treatment of Radiation Fibrosis
Primary Purpose
Radiation Fibrosis
Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Standard OT
PhysioTouch
Sponsored by
About this trial
This is an interventional treatment trial for Radiation Fibrosis
Eligibility Criteria
Inclusion Criteria:
- History of radiation therapy for breast cancer
- Clinical or suspected RFS
- Reported functional impairments
Exclusion Criteria:
- Metastatic disease of soft tissue
- History of bilateral radiation therapy
- Previously diagnosed shoulder impairments not related to RFS
- Prior treatment with PhysioTouch
- Current or recent pregnancy
- Current breastfeeding
- Other contraindications to safe and meaningful participation at discretion of study team
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Standard OT
PhysioTouch
Arm Description
Outcomes
Primary Outcome Measures
Change in self-reported upper extremity function
Self-reported upper extremity function as measured by QuickDash
Change in self-reported pain
Self-reported upper extremity pain as measured by the BPI
Secondary Outcome Measures
Change in affected shoulder abduction
Degrees of should abduction as measured by OT
Change in affected shoulder flexion
Degrees of should flexsion as measured by OT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03496909
Brief Title
PhysioTouch for Treatment of Radiation Fibrosis
Official Title
The PhysioTouch, A Novel Treatment for Radiation Fibrosis Syndrome in Breast Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Reduction in available resources
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
April 2020 (Anticipated)
Study Completion Date
April 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A quarter of a million women will develop breast cancer (BC) in this year alone. Many of these women will have side effects as a result of their breast cancer treatment. Radiation Fibrosis Syndrome (RFS) is a common complication from breast cancer treatment that progressively changes tissue and can cause decreased function, pain, and range of motion. The PhysioTouch is a hand held device that can be used to treat RFS and may improve the treatment of fibrotic tissue. This pilot randomized controlled trial aims to determine the efficacy of using the PhysioTouch in addition to current standard of care for treatment of BC-related RFS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiation Fibrosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Standard OT
Arm Type
Active Comparator
Arm Title
PhysioTouch
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Standard OT
Intervention Description
12 weekly sessions of occupational therapy tailored to patients with RFS secondary to breast cancer treatment. Sessions can include manual therapy, education, and active and passive range-of-motion, etc.
Intervention Type
Behavioral
Intervention Name(s)
PhysioTouch
Intervention Description
12 weekly sessions of occupational therapy tailored to patients with RFS secondary to breast cancer treatment. Sessions can include use of the PhysioTouch electronic massager in lieu of manual therapy, education, and active and passive range-of-motion, etc.
Primary Outcome Measure Information:
Title
Change in self-reported upper extremity function
Description
Self-reported upper extremity function as measured by QuickDash
Time Frame
Baseline to 12 weeks
Title
Change in self-reported pain
Description
Self-reported upper extremity pain as measured by the BPI
Time Frame
Baseline to 12 weeks
Secondary Outcome Measure Information:
Title
Change in affected shoulder abduction
Description
Degrees of should abduction as measured by OT
Time Frame
Baseline to 12 weeks
Title
Change in affected shoulder flexion
Description
Degrees of should flexsion as measured by OT
Time Frame
Baseline to 12 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of radiation therapy for breast cancer
Clinical or suspected RFS
Reported functional impairments
Exclusion Criteria:
Metastatic disease of soft tissue
History of bilateral radiation therapy
Previously diagnosed shoulder impairments not related to RFS
Prior treatment with PhysioTouch
Current or recent pregnancy
Current breastfeeding
Other contraindications to safe and meaningful participation at discretion of study team
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Katie Rogers, MSOTR-CLT
Organizational Affiliation
Michigan Medicine, Department of Physical Medicine & Rehabiliation
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
PhysioTouch for Treatment of Radiation Fibrosis
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