PhysioTouch for Treatment of Radiation Fibrosis

Study Overview
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Brief Summary
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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.

Official Title
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The PhysioTouch, A Novel Treatment for Radiation Fibrosis Syndrome in Breast Cancer Patients

Conditions
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Radiation Fibrosis

Intervention / Treatment
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* Behavioral: Standard OT
* Behavioral: PhysioTouch


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard OT<br> | Behavioral: Standard OT<br>* 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.<br>|
| Experimental: PhysioTouch<br> | Behavioral: PhysioTouch<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in self-reported upper extremity function | Self-reported upper extremity function as measured by QuickDash | Baseline to 12 weeks | 
| Change in self-reported pain | Self-reported upper extremity pain as measured by the BPI | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in affected shoulder abduction | Degrees of should abduction as measured by OT | Baseline to 12 weeks | 
| Change in affected shoulder flexion | Degrees of should flexsion as measured by OT | Baseline to 12 weeks |