Radiation Fibrosis Clinical Trial
Official title:
The PhysioTouch, A Novel Treatment for Radiation Fibrosis Syndrome in Breast Cancer Patients
NCT number | NCT03496909 |
Other study ID # | 00130272 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | December 2018 |
Est. completion date | April 2020 |
Verified date | March 2019 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |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 |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
University of Michigan |
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 |
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