Physical Therapy for Breast Cancer

Overseen By Linda A Koehler, PhD, PT, CLT-LANA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Masonic Cancer Center, University of Minnesota

Disqualifiers: Terminal cancer, Upper extremity DVT, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how physical therapy might aid shoulder movement, pain, and swelling (lymphedema) in individuals with axillary web syndrome (AWS) following breast cancer surgery. AWS can cause tight bands under the skin, leading to discomfort and movement issues. The study consists of two parts: one compares women with and without AWS, while the other tests physical therapy against standard care in individuals with AWS. It seeks participants who have undergone breast cancer surgery with lymph node removal. Those experiencing shoulder issues or swelling after such surgery may find this study suitable. As an unphased trial, this study offers a unique opportunity to contribute to understanding how physical therapy can enhance life after breast cancer surgery.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that physical therapy is safe for individuals with axillary web syndrome following breast cancer surgery?

Research has shown that physical therapy is generally safe for breast cancer patients. Studies have found that it can improve quality of life and help reduce treatment side effects. For instance, one study reported a 12% improvement in thinking skills after a 12-week exercise program for breast cancer patients. Physical therapy is also linked to less pain, better movement, and overall well-being. These findings suggest that physical therapy is well-tolerated and beneficial, with few reports of negative effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about exploring physical therapy as a treatment for breast cancer recovery because it potentially offers a non-invasive way to improve patients' quality of life. Unlike typical treatments like surgery, chemotherapy, or radiation, physical therapy focuses on enhancing physical function and reducing symptoms like fatigue and pain without additional medical interventions. It can be personalized to fit each patient's needs, providing a holistic approach to recovery that complements standard medical care. This trial aims to uncover how effective physical therapy can be as a supportive treatment, potentially setting a new standard for post-treatment care in breast cancer patients.

What evidence suggests that physical therapy is effective for axillary web syndrome?

Research has shown that physical therapy, which participants in this trial may receive, can benefit breast cancer patients, particularly those with axillary web syndrome (AWS). Studies have found that physical therapy improves arm movement, boosts overall physical ability, and reduces tiredness. It also seems to enhance quality of life and might lower the risk of cancer recurrence. One study reported a 12% improvement in thinking skills among breast cancer patients after a 12-week exercise program. Overall, physical therapy proves to be a useful way to manage side effects and enhance the well-being of breast cancer patients. ^{1 3 4 6 7}

Who Is on the Research Team?

Linda Koehler, PhD, PT, CLT-LANA

Principal Investigator

University of Minnesota, Division of Physical Therapy

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Voluntary written consent signed before performance of any study-related procedure not part of normal medical care

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

I am scheduled for breast surgery that includes removing at least one lymph node.

Exclusion Criteria

I do not have a medical condition that would stop me from joining the study.

I have had a deep vein clot in my arm before.

I had breast cancer surgery without lymph node removal.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Prospective Study

Quantify the association between axillary web syndrome (AWS) and metastatic disease and chronic morbidities

1 year

Phase 2: Randomized Controlled Trial

Quantify the effects of physical therapy compared to a control group in individuals with AWS following breast cancer surgery

1 year

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 year

What Are the Treatments Tested in This Trial?

Interventions

• Physical Therapy

Trial Overview 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.

How Is the Trial Designed?

Group I: Physical Therapy Group Experimental Treatment 1 Intervention

Group II: Control Group Active Control 1 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.

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

Published Research Related to This Trial

The Strength after Breast Cancer (SABC) program was successfully implemented in outpatient rehabilitation clinics, with 76% of surveyed clinicians adopting it and 93% continuing to deliver the program, indicating strong sustainability.

The program reached an average of 13 patients per clinic, primarily through referrals from oncology clinics, although barriers such as lack of referrals and competing clinic demands were noted, highlighting areas for improvement in implementation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementing Strength after Breast Cancer (SABC) in outpatient rehabilitation clinics: mapping clinician survey data onto key implementation outcomes. Calo, WA., Doerksen, SE., Spanos, K., et al.[2022]

Among 528 breast cancer survivors surveyed, low-income individuals reported more physical impairments, such as muscle weakness and pain, compared to those with higher incomes, highlighting a disparity in health outcomes.

Despite the higher prevalence of impairments, physical therapy utilization was generally low, indicating a potential under-utilization of PT services, especially among low-income survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical impairments and physical therapy services for minority and low-income breast cancer survivors. Flores, AM., Nelson, J., Sowles, L., et al.[2020]

The PREOPtimize study will evaluate a prehabilitation program combining Nordic Walking, resistance training, and health education for 64 breast cancer patients undergoing neoadjuvant therapy, aiming to improve postoperative arm functionality and overall recovery.

This randomized controlled trial will assess various outcomes, including arm functionality, pain, and quality of life, potentially demonstrating that prehabilitation is a beneficial and feasible intervention for enhancing recovery in breast cancer patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prehabilitation in Patients With Breast Cancer Receiving Neoadjuvant Therapy to Minimize Musculoskeletal Postoperative Complications and Enhance Recovery (PREOPtimize): A Protocol for a Randomized Controlled Trial. Casanovas-Álvarez, A., Sebio-Garcia, R., Ciendones, M., et al.[2023]

Prehabilitation for breast cancer survivors is an emerging area that aims to reduce both short- and long-term side effects of cancer treatment, but it is not yet widely studied compared to rehabilitation.

The review suggests five key components for effective prehabilitation: total body exercise, locoregional exercise, nutritional optimization, stress reduction/psychosocial support, and smoking cessation, which could improve outcomes for women undergoing breast cancer treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Case for Prehabilitation Prior to Breast Cancer Treatment. Santa Mina, D., Brahmbhatt, P., Lopez, C., et al.[2018]

The study demonstrated that self-measurement of arm circumference and shoulder range of motion by women after breast cancer surgery is both feasible and reliable, with high participant retention (94%) and ease of measurement reported at 8.0 out of 10.

The reliability of self-assessments was excellent, with intrarater and interrater reliability scores indicating strong agreement between self-reported and therapist-assessed measurements, suggesting that this method could effectively aid in early detection of upper body issues post-surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Self-Managed Surveillance for Breast Cancer-Related Upper Body Issues: A Feasibility and Reliability Study. Rafn, BS., Singh, CA., Midtgaard, J., et al.[2020]

In a study involving breast cancer survivors at risk for lymphedema, weightlifting showed a higher rate of musculoskeletal injuries compared to standard care, with injury rates of 2.3 per 1,000 bouts for the weightlifting group.

Despite the efficacy of weightlifting as a rehabilitative exercise, 20.9% of participants required medical attention that led to modifications in their exercise regimen, highlighting the need for well-trained health and fitness professionals to safely implement such programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of weightlifting among women with or at risk for breast cancer-related lymphedema: musculoskeletal injuries and health care use in a weightlifting rehabilitation trial. Brown, JC., Troxel, AB., Schmitz, KH.[2021]

A 12-week physical activity intervention delivered by trained breast cancer survivor volunteers significantly increased moderate to vigorous physical activity among participants, with an increase of 103 minutes per week at 12 weeks and 34.7 minutes per week at 24 weeks compared to a control group.

This study demonstrates that utilizing peer volunteers from existing programs, like the American Cancer Society's Reach to Recovery, can effectively expand access to beneficial physical activity programs for breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Peers promoting physical activity among breast cancer survivors: A randomized controlled trial. Pinto, BM., Stein, K., Dunsiger, S.[2022]

Physical activity is essential for preventing breast cancer and improving the quality of life for patients diagnosed with the disease, as it helps counteract the negative effects of treatment on physical activity levels and well-being.

Comprehensive rehabilitation for breast cancer includes preoperative, perioperative, and postoperative exercise programs, focusing on strength, aerobic training, and shoulder mobility, which have been shown to enhance quality of life and reduce fatigue in patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Breast cancer rehabilitation. Líška, D., Rutkowski, S.[2022]

A tailored, exercise-based physical therapy program for patients with metastatic breast cancer showed a high participation rate of 34% and a median adherence of 90%, indicating good feasibility and safety with no major adverse events reported.

Out of the patients who completed the program, 52% achieved their main goals, and 85% expressed a willingness to recommend the program, highlighting its positive impact on patient satisfaction and perceived physical functioning.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of a goal-directed physical therapy program for patients with metastatic breast cancer. Groen, WG., Ten Tusscher, MR., Verbeek, R., et al.[2021]

Breast cancer treatment can lead to complications such as pulmonary issues and upper extremity problems, which can affect the quality of life for survivors, highlighting the need for effective rehabilitation strategies.

Physiotherapy plays a crucial role in managing these complications by preventing and treating conditions like lymphoedema and scar adherence, as well as improving pain management, range of motion, muscle strength, and posture in breast cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Morbidity after breast cancer treatment and physiotherapeutic performance. Gomide, LB., Matheus, JP., Candido dos Reis, FJ.[2007]

A creative therapeutic exercise program, including supervised group dance sessions, has been integrated into the preoperative and postoperative care for breast cancer patients since 1982, emphasizing the importance of physical therapy in their recovery.

This approach not only addresses the physical rehabilitation needs but also supports emotional well-being, helping patients adjust to changes in body image and fostering a positive attitude through shared experiences in a supportive group setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical therapy and dance in the surgical management of breast cancer. A clinical report. Molinaro, J., Kleinfeld, M., Lebed, S.[2019]

Women undergoing mastectomy and breast reconstruction for breast cancer often experience musculoskeletal impairments, highlighting the need for targeted physical therapy interventions.

Physical therapists play a crucial role in the recovery process by providing individualized exercise prescriptions, educating patients, and collaborating closely with physicians to address musculoskeletal dysfunctions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The role of physical therapy in the rehabilitation of patients with mastectomy and breast reconstruction. McAnaw, MB., Harris, KW.[2019]

Citations

1. biosignaling.biomedcentral.com biosignaling.biomedcentral.com/articles/10.1186/s12964-024-01634-6

Outcomes of physical exercises on initiation, progression, and ... Evidence has suggested that participation in physical activity is correlated with a decrease in reappearance and fatality rates of breast cancer patients.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9823038/

A systematic review of multimodal prehabilitation in breast ... Prehabilitation for patients with breast cancer is an emerging research area that appears to improve outcomes.

3. academic.oup.com academic.oup.com/ptj/article-abstract/104/12/pzae151/7826672

Effectiveness of an Exercise and Educational-Based ... A prehabilitation program was able to maintain arm function and increase functional capacity while decreasing fatigue in patients with breast cancer receiving ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12314216/

Exploring the Impact of Physical Therapy on Patient ... (2021) reported a 12% improvement in cognitive function in 70 breast cancer patients after a 12-week exercise program [39]. Psychosocial ...

5. asco.org asco.org/abstracts-presentations/ABSTRACT405272

Physical therapy and rehabilitation for improvement of ... Conclusions: Our study proved that physical therapy and rehabilitation can be useful in improving the quality of life of breast cancer patients undergoing ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9782413/

Impact of physical exercise programs in breast cancer ... Physical exercise reduces the impact of treatment-related adverse events to promote a better quality of life and functional outcomes.

7. nature.com nature.com/articles/s41591-024-03143-y

Supervised, structured and individualized exercise in ... Our results indicate that the exercise intervention not only had a positive effect on physical fatigue and HRQOL but also on pain and dyspnea.