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

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).

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Single (Outcomes Assessor)
  • Study Primary Completion Date: December 2023

Interventions

  • 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.

Arms, Groups and Cohorts

  • 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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

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

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Masonic Cancer Center, University of Minnesota
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Linda Koehler, PhD, PT, CLT-LANA, Principal Investigator, University of Minnesota, Division of Physical Therapy
  • Overall Contact(s)
    • Linda A Koehler, PhD, PT, CLT-LANA, 612-626-1502, koeh0139@umn.edu

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.