Clinical trial · Interventional
Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Physical Therapy: Dependent on Patient's Needs | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control Group
- description
- Patient will not receive physical therapy treatment or further instruction from the research team. The patient will receive standard care recommended by their medical provider which may or may not include physical therapy treatment.
- type
- EXPERIMENTAL
- label
- Physical Therapy Group
- interventionNames
- Behavioral: Physical Therapy: Dependent on Patient's Needs
Primary outcomes (2)
- measure
- Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)
- timeFrame
- 1 Year
- description
- Status of lymph nodes in women who have preoperative AWS (lymph node metastasis present or not)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 18 * Patients (female or male) with a tissue diagnosis of non-invasive or invasive breast cancer * Planned surgical breast cancer treatment (lumpectomy or mastectomy) with a minimum removal of one axillary lymph node by sentinel node biopsy. Contralateral prophylactic mastectomy or bilateral mastectomy is allowed. * Voluntary written consent signed before performance of any study-related procedure not part of normal medical care Exclusion Criteria: * Patients (patients unable to travel easily to the University of Minnesota Medical Center for post-surgery visits). * Synchronous bilateral breast cancer * Presence of a medical complication that would prevent the patient from being able to participate in the study, such as terminal cancer * Previous history of upper extremity deep vein thrombosis * Breast cancer surgery without lymph node removal
References
Publications (0)
Data not yet available