Clinical trial NCT04225572: Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)
Official title: Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Cancer
Lead sponsor: Masonic Cancer Center, University of Minnesota
Sponsor class: OTHER
First posted: 2020-01-13
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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).


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

Primary outcomes:
measure: Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)
timeFrame: 1 Year
measure: Treatment Effects
timeFrame: 1 Year
Secondary outcomes:
measure: Pain level
timeFrame: 1 Year
measure: Function
timeFrame: 1 Year
measure: Lymphedema
timeFrame: 1 Year
measure: Physical activity
timeFrame: 1 Year
measure: Axillary web syndrome status
timeFrame: 1 Year
measure: Preoperative AWS and a positive lymph node status
timeFrame: 1 Year
measure: Abduction range of motion (ROM)
timeFrame: 1 month
measure: DASH Score
timeFrame: 1 Month
measure: Body mass index (BMI)
timeFrame: 1 month
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Masonic Cancer Center
state: Minnesota
Study officials:
affiliation: University of Minnesota, Division of Physical Therapy
name: Linda Koehler, PhD, PT, CLT-LANA
role: PRINCIPAL_INVESTIGATOR
References: