Radiation FibrosisNCT03496909
PhysioTouch for Treatment of Radiation Fibrosis
A study testing Standard OT and PhysioTouch in people with Radiation Fibrosis, run by University of Michigan.
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… Read more about this study
- Who is it for?
- Ages 21 to 65 years, women only
- Conditions the study is for
- Radiation Fibrosis
- What is being tested?
- Standard OT and PhysioTouch
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2018to Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- History of radiation therapy for breast cancer
- Clinical or suspected RFS
- Reported functional impairments
Who cannot join
- 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
About this study
Official title: 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.
- Conditions
- Radiation Fibrosis
- Being tested
- Standard OT, PhysioTouch
- Medical subject headings
- Radiation Fibrosis Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard OTBehavioural
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.
PhysioTouchBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard OT | Active comparator | Not described Receives: Behavioral: Standard OT |
| PhysioTouch | Experimental | Not described Receives: Behavioral: PhysioTouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self-reported upper extremity function
Self-reported upper extremity function as measured by QuickDash
Measured: Baseline to 12 weeks
Change in self-reported pain
Self-reported upper extremity pain as measured by the BPI
Measured: Baseline to 12 weeks
Secondary outcomes (2)
Change in affected shoulder abduction
Degrees of should abduction as measured by OT
Measured: Baseline to 12 weeks
Change in affected shoulder flexion
Degrees of should flexsion as measured by OT
Measured: Baseline to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2018
- Study startDec 2018 (estimated)
- Primary completionApr 2020 (estimated)
- Study completionApr 2020 (estimated)
Why it stopped: Reduction in available resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation FibrosisStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katie Rogers, University of Michigan
- Investigators
- Katie Rogers, MSOTR-CLT, Principal investigator, Michigan Medicine, Department of Physical Medicine & Rehabiliation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03496909
- Sponsor's protocol ID
- 00130272
- Status last verified
- Mar 2019
- First submitted
- 5 Apr 2018
- Last updated
- 6 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The PhysioTouch, A Novel Treatment for Radiation Fibrosis Syndrome in Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03496909
- Acronym / sponsor ID
- 00130272
- Conditions
- Radiation Fibrosis
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Reduction in available resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Study start
- Dec 2018 (estimated)
- Primary completion
- Apr 2020 (estimated)
- Study completion
- Apr 2020 (estimated)
- First posted
- 12 Apr 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard OT | Active comparator | Behavioral: Standard OT |
| PhysioTouch | Experimental | Behavioral: PhysioTouch |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- History of radiation therapy for breast cancer
- Clinical or suspected RFS
- Reported functional impairments
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard OT12 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. | Behavioural | Standard OT |
| PhysioTouch12 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. | Behavioural | PhysioTouch |
Primary outcome
Change in self-reported upper extremity function
Time frame: Baseline to 12 weeks
Self-reported upper extremity function as measured by QuickDash
Change in self-reported pain
Time frame: Baseline to 12 weeks
Self-reported upper extremity pain as measured by the BPI
2 secondary outcomes
Change in affected shoulder abduction
Time frame: Baseline to 12 weeks
Change in affected shoulder flexion
Time frame: Baseline to 12 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Katie Rogers, MSOTR-CLT principal investigator
Michigan Medicine, Department of Physical Medicine & Rehabiliation
Questions about this trial
What is this clinical trial studying?
A study testing Standard OT and PhysioTouch in people with Radiation Fibrosis, run by University of Michigan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 6 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self-reported upper extremity function (time frame: Baseline to 12 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2019.