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

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).

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Behavioral: Physical Therapy: Dependent on Patient's Needs

• Study Type: Interventional
• Enrollment (Estimated): 200
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Linda A Koehler, PhD, PT, CLT-LANA; Phone Number: 612-626-1502; Email: koeh0139@umn.edu

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55455
      • Recruiting
      • University of Minnesota Masonic Cancer Center
      • Contact: Linda Koehler; Phone Number: 612-626-1502; Email: koeh0139@umn.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group; 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.
Experimental: Physical Therapy Group	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)	Status of lymph nodes in women who have preoperative AWS (lymph node metastasis present or not)	1 Year
Treatment Effects	Range of motion (ROM) will be measured using a standard goniometer	1 Year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain level	Measured by 0-10 scale and Penn Shoulder Score questionaire	1 Year
Function	Disabilities of the Arm, Shoulder and Hand questionaire	1 Year
Lymphedema	Measured by girth measures, tissue dielectic constant and bioimpedance spectroscopy	1 Year
Physical activity	Measured by International Physical Activity Questionaire IPAQ (short form)	1 Year
Axillary web syndrome status	(present/not present) based on palpable assessment by investigator	1 Year
Preoperative AWS and a positive lymph node status	Correlation between AWS and a positive lymph node status	1 Year
Abduction range of motion (ROM)	ROM measured by a standard goniometer	1 month
DASH Score	Measured by Disabilities of the Arm, Shoulder, and Hand questionnaire	1 Month
Body mass index (BMI)	Difference in body mass index (BMI) between patients with and without AWS (pre and post operative)	1 month

Collaborators and Investigators

• Sponsor: Masonic Cancer Center, University of Minnesota
• Investigators: Principal Investigator: Linda Koehler, PhD, PT, CLT-LANA, University of Minnesota, Division of Physical Therapy

Study record dates

Study Major Dates

• Study Start (Actual): December 27, 2017
• Primary Completion (Estimated): December 1, 2025
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: September 24, 2019
• First Submitted That Met QC Criteria: January 9, 2020
• First Posted (Actual): January 13, 2020

Study Record Updates

• Last Update Posted (Estimated): February 6, 2024
• Last Update Submitted That Met QC Criteria: February 5, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 2017NTLS119; PMR-2017-26231 (Other Identifier: University of Minnesota Masonic Cancer Center)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No