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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer

• Registration Number: NCT04225572
• Lead Sponsor: Masonic Cancer Center, University of Minnesota

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2017-12-27
• Study First Submitted: 2019-09-24
• Study First Submitted QC: 2020-01-09
• Study First Posted: 2020-01-13
• Primary Completion: 2024-12-12
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-03
• Last Update Posted: 2025-01-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 135

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

University of Minnesota Masonic Cancer Center; 🇺🇸 Minneapolis, Minnesota, United States