Breast Cancer Clinical Trial

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

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).

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Breast Cancer

Estimated Enrollment:

200

Study ID:

NCT04225572

Recruitment Status:

Recruiting

Sponsor:

Masonic Cancer Center, University of Minnesota

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There is 1 Location for this study

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University of Minnesota Masonic Cancer Center
Minneapolis Minnesota, 55455, United States More Info
Linda Koehler
Contact
612-626-1502
[email protected]

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Study is for people with:

Breast Cancer

Estimated Enrollment:

200

Study ID:

NCT04225572

Recruitment Status:

Recruiting

Sponsor:


Masonic Cancer Center, University of Minnesota

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