PhysioTouch for Treatment of Radiation Fibrosis

March 4, 2019 updated by: Katie Rogers, University of Michigan

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

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Standard OT
Behavioral: Standard OT
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.
Experimental: PhysioTouch
Behavioral: PhysioTouch
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in self-reported upper extremity function
Time Frame: Baseline to 12 weeks
Self-reported upper extremity function as measured by QuickDash
Baseline to 12 weeks
Change in self-reported pain
Time Frame: Baseline to 12 weeks
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
Time Frame: Baseline to 12 weeks
Degrees of should abduction as measured by OT
Baseline to 12 weeks
Change in affected shoulder flexion
Time Frame: Baseline to 12 weeks
Degrees of should flexsion as measured by OT
Baseline to 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Michigan

Investigators

  • Principal Investigator: Katie Rogers, MSOTR-CLT, Michigan Medicine, Department of Physical Medicine & Rehabiliation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

December 1, 2018

Primary Completion (Anticipated)

April 1, 2020

Study Completion (Anticipated)

April 1, 2020

Study Registration Dates

First Submitted

April 5, 2018

First Submitted That Met QC Criteria

April 5, 2018

First Posted (Actual)

April 12, 2018

Study Record Updates

Last Update Posted (Actual)

March 6, 2019

Last Update Submitted That Met QC Criteria

March 4, 2019

Last Verified

March 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 00130272

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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