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

135 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

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 data supports the idea that Physical Therapy for Breast Cancer is an effective treatment?

The available research shows that physical therapy can be an effective treatment for breast cancer patients. One study highlights a prehabilitation program that includes exercises like Nordic Walking and resistance training, which helps improve arm function after surgery. Another report describes a program combining physical therapy with dance, which not only aids physical recovery but also supports emotional well-being and body image adjustment. These studies suggest that physical therapy can enhance recovery and provide emotional support, making it a beneficial treatment for breast cancer patients. ^{1 2 3 4 5}

What data supports the effectiveness of this treatment for breast cancer?

Research suggests that physical therapy, including prehabilitation exercises and rehabilitation therapy, can help improve arm function and enhance recovery after breast cancer surgery. Programs that include exercises like Nordic Walking and resistance training, as well as creative therapies like dance, have shown benefits in improving physical and emotional well-being for breast cancer patients. ^{1 2 3 4 5}

What safety data exists for physical therapy in breast cancer treatment?

The safety of physical therapy for breast cancer patients has been evaluated in various studies. One study focused on the safety of weightlifting for women with or at risk for breast cancer-related lymphedema, highlighting musculoskeletal injuries and healthcare use. Another study, 'Strength after Breast Cancer (SABC),' established the efficacy of a rehabilitative exercise program in a large randomized controlled trial and assessed its implementation in outpatient clinics. Additionally, physical therapy is recognized for its role in managing musculoskeletal impairments post-mastectomy and breast reconstruction, emphasizing the importance of communication between physicians and therapists. Prehabilitation, which includes exercise and other health optimizations before treatment, is also discussed as a way to mitigate treatment-related sequelae. Overall, these studies suggest that physical therapy is a safe and beneficial component of breast cancer treatment, with proper implementation and training. ^{6 7 8 9 10}

Is physical therapy safe for breast cancer patients?

Research shows that physical therapy, including weightlifting and exercise programs, is generally safe for breast cancer survivors, with low rates of musculoskeletal injuries and healthcare referrals. Programs like Strength after Breast Cancer (SABC) have been developed to safely support recovery and rehabilitation. ^{6 7 8 9 10}

Is physical therapy a promising treatment for breast cancer?

Yes, physical therapy is a promising treatment for breast cancer. It helps improve quality of life by reducing pain, increasing movement, and strengthening muscles. It also supports recovery after surgery and can prevent complications like swelling and stiffness. Physical therapy is an important part of a team approach to breast cancer care. ^{1 6 7 11 12}

How does physical therapy differ from other treatments for breast cancer?

Physical therapy for breast cancer is unique because it focuses on rehabilitation and prehabilitation (pre-treatment preparation) to address musculoskeletal issues and improve quality of life. It includes personalized exercise plans, stress reduction, and nutritional support, which are not typically part of standard cancer treatments like surgery or chemotherapy. ^{1 2 6 7 11}

Research Team

Linda Koehler, PhD, PT, CLT-LANA

Principal Investigator

University of Minnesota, Division of Physical Therapy

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Self-Managed Surveillance for Breast Cancer-Related Upper Body Issues: A Feasibility and Reliability Study. [2020]

2. Switzerland pubmed.ncbi.nlm.nih.gov

Physical impairments and physical therapy services for minority and low-income breast cancer survivors. [2020]

3. United States 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. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Physical therapy and dance in the surgical management of breast cancer. A clinical report. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

Feasibility and outcomes of a goal-directed physical therapy program for patients with metastatic breast cancer. [2021]

6. Netherlands pubmed.ncbi.nlm.nih.gov

The role of physical therapy in the rehabilitation of patients with mastectomy and breast reconstruction. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

The Case for Prehabilitation Prior to Breast Cancer Treatment. [2018]

8. England 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Implementing Strength after Breast Cancer (SABC) in outpatient rehabilitation clinics: mapping clinician survey data onto key implementation outcomes. [2022]

10. United States pubmed.ncbi.nlm.nih.gov

Peers promoting physical activity among breast cancer survivors: A randomized controlled trial. [2022]

11. India pubmed.ncbi.nlm.nih.gov

Morbidity after breast cancer treatment and physiotherapeutic performance. [2007]

12. Czech Republic pubmed.ncbi.nlm.nih.gov

Breast cancer rehabilitation. [2022]