An interventional study of Physical Therapy: Dependent on Patient's Needs in Breast Cancer, sponsored by Masonic Cancer Center, University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-07.
Sponsored by Masonic Cancer Center, University of Minnesota · Not applicable, Interventional, and Supportive care
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).
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 135 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Masonic Cancer Center, University of Minnesota is the lead sponsor of 284 studies on the registry; 34 are open to participants now.
Of its 39 completed or terminated interventional studies of FDA-regulated products, 28 (72%) have results posted.
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Exclusion Criteria:
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.
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.
Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)
Status of lymph nodes in women who have preoperative AWS (lymph node metastasis present or not)
Time frame: 1 Year
Treatment Effects
Range of motion (ROM) will be measured using a standard goniometer
Time frame: 1 Year
Pain level
Measured by 0-10 scale and Penn Shoulder Score questionaire
Time frame: 1 Year
Function
Disabilities of the Arm, Shoulder and Hand questionaire
Time frame: 1 Year
Lymphedema
Measured by girth measures, tissue dielectic constant and bioimpedance spectroscopy
Time frame: 1 Year
Physical activity
Measured by International Physical Activity Questionaire IPAQ (short form)
Time frame: 1 Year
Axillary web syndrome status
(present/not present) based on palpable assessment by investigator
Time frame: 1 Year
Preoperative AWS and a positive lymph node status
Correlation between AWS and a positive lymph node status
Time frame: 1 Year
Abduction range of motion (ROM)
ROM measured by a standard goniometer
Time frame: 1 month
DASH Score
Measured by Disabilities of the Arm, Shoulder, and Hand questionnaire
Time frame: 1 Month
Body mass index (BMI)
Difference in body mass index (BMI) between patients with and without AWS (pre and post operative)
Time frame: 1 month
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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Masonic Cancer Center, University of Minnesota