Breast CancerNCT04225572
Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)
A study testing Physical Therapy: Dependent on Patient's Needs in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Physical Therapy: Dependent on Patient's Needs
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Dec 2017to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Masonic Cancer Center
Minneapolis, Minnesota, 55455
About this study
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).
- Conditions
- Breast Cancer
- Being tested
- Physical Therapy: Dependent on Patient's Needs
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical Therapy: Dependent on Patient's NeedsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | No intervention | 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. |
| Physical Therapy Group | Experimental | Not described Receives: Behavioral: Physical Therapy: Dependent on Patient's Needs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)
Status of lymph nodes in women who have preoperative AWS (lymph node metastasis present or not)
Measured: 1 Year
Treatment Effects
Range of motion (ROM) will be measured using a standard goniometer
Measured: 1 Year
Secondary outcomes (9)
Pain level
Measured by 0-10 scale and Penn Shoulder Score questionaire
Measured: 1 Year
Function
Disabilities of the Arm, Shoulder and Hand questionaire
Measured: 1 Year
Lymphedema
Measured by girth measures, tissue dielectic constant and bioimpedance spectroscopy
Measured: 1 Year
Physical activity
Measured by International Physical Activity Questionaire IPAQ (short form)
Measured: 1 Year
Axillary web syndrome status
(present/not present) based on palpable assessment by investigator
Measured: 1 Year
Preoperative AWS and a positive lymph node status
Correlation between AWS and a positive lymph node status
Measured: 1 Year
Abduction range of motion (ROM)
ROM measured by a standard goniometer
Measured: 1 month
DASH Score
Measured by Disabilities of the Arm, Shoulder, and Hand questionnaire
Measured: 1 Month
Body mass index (BMI)
Difference in body mass index (BMI) between patients with and without AWS (pre and post operative)
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study start27 Dec 2017
- Primary completion12 Dec 2024
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Linda Koehler, PhD, PT, CLT-LANA, Principal investigator, University of Minnesota, Division of Physical Therapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04225572
- Sponsor's protocol ID
- 2017NTLS119
- Other IDs
- PMR-2017-26231
- Status last verified
- Jan 2026
- First submitted
- 24 Sep 2019
- Last updated
- 7 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)
- ClinicalTrials.gov ID
- NCT04225572
- Acronym / sponsor ID
- 2017NTLS119
- Conditions
- Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- 27 Dec 2017 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 13 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | No intervention | –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. |
| Physical Therapy Group | Experimental | Behavioral: Physical Therapy: Dependent on Patient's Needs |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical Therapy: Dependent on Patient's NeedsTherapeutic 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. | Behavioural | Physical Therapy Group |
Primary outcome
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
9 secondary outcomes
Pain level
Time frame: 1 Year
Function
Time frame: 1 Year
Lymphedema
Time frame: 1 Year
Physical activity
Time frame: 1 Year
Axillary web syndrome status
Time frame: 1 Year
Preoperative AWS and a positive lymph node status
Time frame: 1 Year
Abduction range of motion (ROM)
Time frame: 1 month
DASH Score
Time frame: 1 Month
Body mass index (BMI)
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Linda Koehler, PhD, PT, CLT-LANA principal investigator
University of Minnesota, Division of Physical Therapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy: Dependent on Patient's Needs in people with Breast Cancer, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical characteristics of preoperative Auxillary Web Syndrome (AWS) (time frame: 1 Year). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.