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Completed

NCT Number: NCT04225572

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).

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Physical Therapy: Dependent on Patient's Needs

Behavioral

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.

Primary outcomes

  1. 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)

  2. Treatment Effects

    Time frame: 1 Year

    Range of motion (ROM) will be measured using a standard goniometer

Secondary outcomes

  1. Pain level

    Time frame: 1 Year

    Measured by 0-10 scale and Penn Shoulder Score questionaire

  2. Function

    Time frame: 1 Year

    Disabilities of the Arm, Shoulder and Hand questionaire

  3. Lymphedema

    Time frame: 1 Year

    Measured by girth measures, tissue dielectic constant and bioimpedance spectroscopy

  4. Physical activity

    Time frame: 1 Year

    Measured by International Physical Activity Questionaire IPAQ (short form)

  5. Axillary web syndrome status

    Time frame: 1 Year

    (present/not present) based on palpable assessment by investigator

  6. Preoperative AWS and a positive lymph node status

    Time frame: 1 Year

    Correlation between AWS and a positive lymph node status

  7. Abduction range of motion (ROM)

    Time frame: 1 month

    ROM measured by a standard goniometer

  8. DASH Score

    Time frame: 1 Month

    Measured by Disabilities of the Arm, Shoulder, and Hand questionnaire

  9. Body mass index (BMI)

    Time frame: 1 month

    Difference in body mass index (BMI) between patients with and without AWS (pre and post operative)

Sponsors and collaborators

Lead sponsor

Masonic Cancer Center, University of Minnesota

Other

Registry information

Important dates

Study start
2017
Primary completion
2024
Study completion
2025
First posted
Jan 13, 2020
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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