PhysioTouch for Treatment of Radiation Fibrosis

Radiation Fibrosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03496909
• Other study ID #: 00130272
• Status: Withdrawn
• Phase: N/A
• Start date: December 2018
• Est. completion date: April 2020

Study information

• Verified date: March 2019
• Source: University of Michigan
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 2020
• Est. primary completion date: April 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibrosis
• Radiation Fibrosis
• Radiation Pneumonitis

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in self-reported upper extremity function	Self-reported upper extremity function as measured by QuickDash	Baseline to 12 weeks
Primary	Change in self-reported pain	Self-reported upper extremity pain as measured by the BPI	Baseline to 12 weeks
Secondary	Change in affected shoulder abduction	Degrees of should abduction as measured by OT	Baseline to 12 weeks
Secondary	Change in affected shoulder flexion	Degrees of should flexsion as measured by OT	Baseline to 12 weeks