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PhysioTouch for Treatment of Radiation Fibrosis

Sponsor
University of Michigan (Other)
Overall Status
Withdrawn
CT.gov ID
NCT03496909
Collaborator
(none)
0
Enrollment
2
Arms
16
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Standard OT
  • Behavioral: PhysioTouch
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
0 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The PhysioTouch, A Novel Treatment for Radiation Fibrosis Syndrome in Breast Cancer Patients
Anticipated Study Start Date :
Dec 1, 2018
Anticipated Primary Completion Date :
Apr 1, 2020
Anticipated Study Completion Date :
Apr 1, 2020

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Change in self-reported upper extremity function [Baseline to 12 weeks]

    Self-reported upper extremity function as measured by QuickDash

  2. Change in self-reported pain [Baseline to 12 weeks]

    Self-reported upper extremity pain as measured by the BPI

Secondary Outcome Measures

  1. Change in affected shoulder abduction [Baseline to 12 weeks]

    Degrees of should abduction as measured by OT

  2. Change in affected shoulder flexion [Baseline to 12 weeks]

    Degrees of should flexsion as measured by OT

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years to 65 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Michigan

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Katie Rogers, Occupational Therapist, University of Michigan
ClinicalTrials.gov Identifier:
NCT03496909
Other Study ID Numbers:
  • 00130272
First Posted:
Apr 12, 2018
Last Update Posted:
Mar 6, 2019
Last Verified:
Mar 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Radiation Pneumonitis
Fibrosis

Study Results

No Results Posted as of Mar 6, 2019