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NCT04225572 · ClinicalTrials.gov registry record · NA
Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)
A NA study, sponsored by Masonic Cancer Center, University of Minnesota.
- Completed
- Registry status
- NA
- Development phase
- 135
- Enrollment target
NCT04225572: Completed NA study, sponsored by Masonic Cancer Center, University of Minnesota.
NCT04225572 is a NA study that has completed, run by Masonic Cancer Center, University of Minnesota. The registered enrollment target is 135 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04225572, a NA study, has completed, sponsored by Masonic Cancer Center, University of Minnesota.
- COMPLETED
- Registry status
- NA
- Development phase
- 135 participants
- Enrollment target
Study Summary
Phase 1: The investigators will conduct a prospective study to quantify the association between axillary web syndrome (AWS) and metastatic disease and chronic morbidities such as lymphedema, shoulder dysfunction, and pain comparing women (i) with AWS and (ii) without AWS in two cohorts of women. (n=200) Phase 2: This is a randomized controlled trial to 1) quantify the effects of (i) physical therapy compared to (ii) a control group in individuals with AWS following breast cancer surgery related to physical activity and physical impairments such as lymphedema, shoulder motion, function, and pain (n=44, 22 in each group). Funding to progress to Phase 2 of this trial has been obtained. It is anticipated 120 subjects participating in Phase 1 will be screened for eligibility for Phase 2 (separate consent and eligibility from Phase 1).
Primary Outcome
Status of lymph nodes in women who have preoperative AWS (lymph node metastasis present or not)
Interventions
- BEHAVIORAL Physical Therapy: Dependent on Patient's Needs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2017-12-27 |
| Est. Completion | 2025-12-12 |
| Phase | NA |
What the finished NCT04225572 record still lists
NCT04225572 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (90% lower).
The record links to 0 conditions, and to 1 intervention - of which Physical Therapy: Dependent on Patient's Needs is the first listed.
NCT04225572 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04225572 about?
NCT04225572 is a clinical study titled "Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)". Phase 1: The investigators will conduct a prospective study to quantify the association between axillary web syndrome (AWS) and metastatic disease and chronic morbidities such as lymphedema, shoulder dysfunction, and pain comparing women (i) with AWS and (ii) without AWS in two cohorts of women. (n=...
What is the current status of trial NCT04225572?
This trial is currently completed. It is a NA study. The enrollment target is 135 participants. The study started on 2017-12-27. Estimated completion is 2025-12-12.
What interventions are being tested in trial NCT04225572?
The interventions under investigation include: Physical Therapy: Dependent on Patient's Needs (BEHAVIORAL).
Who is sponsoring clinical trial NCT04225572?
This trial is sponsored by Masonic Cancer Center, University of Minnesota, which has 249 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04225572's enrollment target sits among peer trials
135 726th of 2000 higher than 1,273 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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