← Back to Search

Physical Therapy for Breast Cancer

N/A

Recruiting

Led By Linda Koehler, PhD, PT, CLT-LANA

Research Sponsored by Masonic Cancer Center, University of Minnesota

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥ 18

Patients (female or male) with a tissue diagnosis of non-invasive or invasive breast cancer

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 1 year

Awards & highlights

Study Summary

This trial will have two phases. In phase one, the investigators will study 200 women, some with axillary web syndrome (AWS) and some without, to see if there is a correlation between AWS and metastatic disease or other conditions such as lymphedema, shoulder dysfunction, and pain. In phase two, which is a randomized controlled trial, the investigators will study 44 women with AWS, half of whom will receive physical therapy and half of whom will serve as a control group. The study will look at physical activity and physical impairments such as lymphedema, shoulder motion, function, and pain to see if physical therapy has

Who is the study for?

The PRE-OPT trial is for adults with breast cancer who are planning to undergo surgery that includes removing at least one lymph node. Participants must be able to give written consent and travel to the study site. Those with terminal illnesses, a history of upper limb blood clots, or bilateral breast cancer at the same time can't join.Check my eligibility

What is being tested?

This two-phase study first examines the link between axillary web syndrome (AWS) and long-term health issues in women after breast cancer surgery. The second phase tests if physical therapy can improve movement, reduce pain, and prevent chronic conditions like lymphedema in patients with AWS compared to those without any treatment.See study design

What are the potential side effects?

Since this trial involves physical therapy tailored to each patient's needs post-breast cancer surgery, side effects may include temporary soreness or discomfort from exercises. However, these are generally mild and manageable under professional guidance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Select...

I have been diagnosed with breast cancer, either non-invasive or invasive.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 1 year

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~1 year

This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Clinical characteristics of preoperative Auxillary Web Syndrome (AWS)

Treatment Effects

Secondary outcome measures

Abduction range of motion (ROM)

Axillary web syndrome status

Body mass index (BMI)

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Physical Therapy GroupExperimental Treatment1 Intervention

Group II: Control GroupActive Control1 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Masonic Cancer Center, University of MinnesotaLead Sponsor

271 Previous Clinical Trials

14,425 Total Patients Enrolled

21 Trials studying Breast Cancer

596 Patients Enrolled for Breast Cancer

Linda Koehler, PhD, PT, CLT-LANAPrincipal InvestigatorUniversity of Minnesota, Division of Physical Therapy

Media Library

Physical Therapy Clinical Trial Eligibility Overview. Trial Name: NCT04225572 — N/A

Physical Therapy 2023 Treatment Timeline for Medical Study. Trial Name: NCT04225572 — N/A

Breast Cancer Research Study Groups: Control Group, Physical Therapy Group

Breast Cancer Clinical Trial 2023: Physical Therapy Highlights & Side Effects. Trial Name: NCT04225572 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What hypotheses does this experiment seek to verify?

"The purpose of this one-year study is to observe the effects of the treatment. Additionally, pain level (measured on a 0-10 scale), function (measured by the Disabilities of the Arm, Shoulder and Hand questionnaire), and DASH score (also measured by the Disabilities of the Arm, Shoulder, and Hand questionnaire) will be monitored as secondary outcomes."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

2017. "Physical Rehabilitation Evaluation and Optimal Physical Therapy (PRE-OPT)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04225572.