NCT04225572

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 135 (actual)
• Sponsor: Masonic Cancer Center, University of Minnesota · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Conditions

• Breast Cancer

Interventions

Type	Name	Description
BEHAVIORAL	Physical Therapy: Dependent on Patient's Needs	Therapeutic exercise: * ROM: Begin with passive upper extremity ROM and progress to active ROM. * Strengthening: Progressive upper extremity resistive exercises starting with light weights. * Aerobic: Select a suitable, individual aerobic exercise program (walking, yoga, etc.) Manual therapy * Soft tissue mobilization, myofascial release, and stretching of identified tight and stiff tissue. Lymphedema treatment * Manual lymph drainage: Gentle lymphatic massage to lymph nodes and vessels by PT for 1-2 weeks. Instruct patient in self MLD to perform 1-2×/day for 10 minutes during the remaining weeks. * Compression therapy: Gradient compression bandaging for daily wear with activities and exercise for 1-2 weeks. Instruct in self compression bandaging or issue a compression garment to wear with exercise or activity, or with worsening symptoms of AWS (i.e. cording extends down arm) or lymphedema.

Timeline

• Start date: 2017-12-27
• Primary completion: 2024-12-12
• Completion: 2025-12-12
• First posted: 2020-01-13
• Last updated: 2026-01-07

Locations

1 site across 1 country: United States