Swimming for Post-Breast Cancer Surgery Complications

Overseen By Natalie Mills, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Ottawa Hospital Research Institute

Disqualifiers: Regular swimmer, Cannot swim, Others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 8 weeks

128 Participants Needed

Trial Summary

What is the purpose of this trial?

Following surgery and treatment for breast cancer, many patients experience swelling of lymph nodes (lymphedema) or accumulation of fluid (seroma) that can cause pain, restrict movement, and reduce quality of life. Current treatments include massage, pressure dressings, and drainage, but these are often ineffective and do not last. Physical activity, in particular swimming, has been linked to improvement in lymphedema/seroma symptoms, but more research is required to determine whether or not this type of treatment is effective.

Do I have to stop taking my current medications for this trial?

The trial protocol does not specify whether you need to stop taking your current medications. It's best to consult with your doctor for guidance.

What data supports the idea that Swimming for Post-Breast Cancer Surgery Complications is an effective treatment?

The available research shows that swimming and aquatic therapy can be effective for women recovering from breast cancer surgery. One study found that aquatic exercises helped improve fatigue, pain, and quality of life. Another study compared aquatic and land exercises and found that both improved mental well-being, but swimming was particularly beneficial for those who continued long-term. Additionally, aqua therapy was shown to reduce arm swelling and improve shoulder movement in women with lymphedema, a common complication after breast cancer surgery. These findings suggest that swimming can be a helpful part of recovery and rehabilitation. ^{1 2 3 4 5}

What safety data exists for swimming as a treatment for post-breast cancer surgery complications?

The research indicates that aquatic therapy, including swimming, is generally safe for breast cancer survivors. The study on long-term participation in water-exercising after breast cancer surgery found that 72% of participants continued exercising without complications. This suggests that swimming and other water-based exercises are safe and well-tolerated by breast cancer survivors. ^{1 3 4 5 6}

Is swimming a promising treatment for complications after breast cancer surgery?

Yes, swimming is a promising treatment for complications after breast cancer surgery. It can help improve fatigue, pain, and quality of life. Swimming also supports mental well-being and encourages long-term exercise habits, thanks to its social and convenient nature. ^{1 3 4 5 7}

Research Team

Natalie Mills, MD

Principal Investigator

Univeristy of Ottawa

Eligibility Criteria

This trial is for adult female patients from the Ottawa Hospital who are post-operative from breast cancer surgery and under 3 years from completing treatment. They must have pain, seroma, or lymphedema symptoms and get approval to swim by their oncologists. It's not for those with medical issues making swimming unsafe, regular swimmers before diagnosis, or non-swimmers.

Inclusion Criteria

I am a woman over 18 receiving care at the Ottawa Hospital.

Must have approval from their medical and radiation oncologist to participate in the study upon enrollment

I have had surgery for breast cancer, with or without lymph node removal and radiation.

Exclusion Criteria

You regularly swam before being diagnosed with breast cancer.

You have health issues that make swimming unsafe for you.

I cannot swim.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants in the experimental group will participate in an 8-week swimming program, involving three weekly swimming sessions of 30 minutes minimum. Control group participants will receive standard care recommendations.

8 weeks

3 visits (in-person) per week for the swimming group; monthly phone questionnaires for both groups

Follow-up

Participants are monitored for safety and effectiveness after treatment, with monthly phone questionnaires for 3 months post-intervention.

3 months

Monthly phone questionnaires

Long-term follow-up

Participants' pain levels are assessed using a visual analog scale (VAS) after the swimming program, lasting approximately 14 months.

14 months

Treatment Details

Interventions

• Swimming

Trial Overview The study investigates whether swimming can help alleviate chronic arm and chest pain, seroma, and lymphedema following breast cancer surgery. Participants will engage in a swimming program to assess its effectiveness compared to traditional treatments like massage or pressure dressings.

Participant Groups

Group I: Experimental Group Experimental Treatment 1 Intervention

In the experimental group, patients allocated to the swimming/experimental group will participate in 8 weeks of the swimming program, which involves three weekly swimming sessions of 30 minutes minimum. They will be asked to undergo a range of motion (ROM) assessment by a registered kinesiologist, as well as a few short questionnaires administered over the phone by a research assistant, once at the onset of the intervention and once a month for 3 months during the intervention.

Group II: Control Group Active Control 1 Intervention

The control group will include patients who receive standard of care. This includes the recommendation to undertake exercise and physiotherapy; however, no formal exercise program will be provided. In the control group, participants will be asked to answer a few short questionnaires administered over the phone by a research assistant once per month for 4 months.

Swimming is already approved in Canada, United States, European Union for the following indications:

Approved in Canada as Breaststroke Swimming for:

• Lymphedema
• Seroma
• Chronic Arm and Chest Pain

Approved in United States as Aquatic Therapy for:

• Lymphedema
• Seroma
• Post-Surgical Rehabilitation

Approved in European Union as Water-Based Exercise for:

• Lymphedema
• Seroma
• Cancer-Related Fatigue

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials

585

Recruited

3,283,000+

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

Bruyere Research Institute

Collaborator

Trials

35

Recruited

2,024,000+

Findings from Research

Aquatic therapeutic exercise significantly improves fatigue, pain, and quality of life in female breast cancer survivors, based on a systematic review of 10 randomized controlled trials involving 606 participants.

While some studies showed immediate reductions in lymphedema volume, the long-term effects on lymphedema remain uncertain, indicating a need for further research in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of aquatic therapeutic exercise efficacy in breast cancer survivors. Muñoz-Gómez, E., Arnal-Gómez, A., López Cascón, A., et al.[2022]

Modified Ai Chi, a slow aquatic exercise, was found to be more effective than conventional faster-paced aquatic therapy in reducing arm volume immediately after the intervention in women with breast cancer-related lymphoedema, with a significant decrease of 140mL on average.

While the reduction in arm volume was not sustained after one hour, 72% of participants experienced a decrease immediately after Ai Chi compared to only 28% after conventional therapy, indicating a potentially beneficial immediate effect of the slower exercise method.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does the speed of aquatic therapy exercise alter arm volume in women with breast cancer related lymphoedema? A cross-over randomized controlled trial. Deacon, R., de Noronha, M., Shanley, L., et al.[2020]

A study involving 90 women, including 60 breast cancer survivors, showed that both aquatic and land exercises significantly improved mental well-being after 6 months, with no major differences between the two types of exercise.

Women who participated in aquatic exercise engaged in more vigorous physical activity compared to those in land exercise, highlighting the importance of regular physical activity in the rehabilitation process after breast cancer surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effect of aquatic and land exercise on the mental well-being of women following breast cancer surgery-comparative study. Czenczek-Lewandowska, E., Szeliga, E., Leszczak, J.[2023]

A study involving 29 women who underwent breast cancer surgery found that 97% continued participating in water-exercising weekly, highlighting its safety and feasibility as a rehabilitation exercise without complications.

Key factors that encouraged these cancer survivors to maintain long-term participation in water-exercising included the ability to easily modify exercises in a supportive environment, social interaction, and access to private facilities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Participation in water-exercising long-term after breast cancer surgery: Experiences of significant factors for continuing exercising as a part of cancer rehabilitation. Enblom, A., Lindquist, H., Bergmark, K.[2018]

Aqua therapy resistance exercise significantly reduced arm volume and pain intensity while improving shoulder range of motion in breast cancer survivors with lymphedema, compared to traditional land-based exercises, after 8 weeks of treatment.

The study involved 50 participants, with results showing a marked improvement in limb volume, shoulder flexion, and abduction range of motion, indicating that aqua therapy may be a more effective intervention for managing post-mastectomy lymphedema.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Aqua Therapy Exercises on Postmastectomy Lymphedema: A Prospective Randomized Controlled Trial. Ali, KM., El Gammal, ER., Eladl, HM.[2021]

Breast cancer patients have a high 5-year survival rate of 88%, but many experience long-term side effects from treatments that negatively impact their quality of life, such as pain and limited mobility.

Regular physical activity, particularly sports like fencing and rowing, has been shown to significantly improve health outcomes, reduce fatigue, and enhance quality of life for breast cancer patients during and after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adapted physical activity for breast cancer patients: shared considerations with two Olympic and world Italian sports champions. Berretta, M., Facchini, BA., Garozzo, D., et al.[2022]

Engaging in physical activity, such as fencing, is recommended for breast cancer survivors to help alleviate fatigue, pain, and improve arm mobility after surgery.

Fencing not only provides physical benefits but also offers psychological advantages, enhancing overall well-being for individuals recovering from breast cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Fencing for promoting health after breast cancer]. Leroy, MF.[2018]

References

1. Germany pubmed.ncbi.nlm.nih.gov

Systematic review of aquatic therapeutic exercise efficacy in breast cancer survivors. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

Does the speed of aquatic therapy exercise alter arm volume in women with breast cancer related lymphoedema? A cross-over randomized controlled trial. [2020]

3. Netherlands pubmed.ncbi.nlm.nih.gov

The effect of aquatic and land exercise on the mental well-being of women following breast cancer surgery-comparative study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Participation in water-exercising long-term after breast cancer surgery: Experiences of significant factors for continuing exercising as a part of cancer rehabilitation. [2018]

5. Korea (South) pubmed.ncbi.nlm.nih.gov

Effect of Aqua Therapy Exercises on Postmastectomy Lymphedema: A Prospective Randomized Controlled Trial. [2021]

6. Italy pubmed.ncbi.nlm.nih.gov

Adapted physical activity for breast cancer patients: shared considerations with two Olympic and world Italian sports champions. [2022]

7. France pubmed.ncbi.nlm.nih.gov

[Fencing for promoting health after breast cancer]. [2018]