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Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)

Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)

Recruiting
18 years and older
All
Phase N/A

Overview

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).

Eligibility

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

Study details
    Breast Cancer
    Breast Cancer

NCT04225572

Masonic Cancer Center, University of Minnesota

16 February 2024

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