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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether swimming can ease pain and improve movement for breast cancer surgery patients with fluid buildup issues like lymphedema (swelling due to lymph fluid) or seroma (fluid accumulation). The study compares regular swimmers with those following their usual care routine, which may include general exercise and physiotherapy recommendations. Women from the Ottawa Hospital who have undergone breast surgery and experience pain or swelling related to their treatment may qualify, provided they have not been regular swimmers before their diagnosis. As an unphased trial, participants can contribute to innovative research that could enhance post-surgery care.

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 prior data suggests that swimming is safe for post-breast cancer surgery patients?

Research has shown that swimming can be a safe and beneficial activity for individuals recovering from breast cancer surgery. In one study, 72% of participants who engaged in water exercises after surgery experienced no complications. Another review found that water exercises, such as swimming, improved quality of life and reduced fatigue in women with breast cancer. Additionally, endurance and strength exercises in water have proven safe and effective during and after cancer treatment. These findings suggest that swimming is generally well-tolerated and could be a safe option for managing post-surgery issues like swelling and fluid buildup. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using swimming as a treatment for post-breast cancer surgery complications because it offers a unique, holistic approach to recovery. Unlike standard care options, such as general exercise recommendations and physiotherapy, swimming provides a gentle, low-impact form of exercise that can improve range of motion and reduce swelling without straining the body. Additionally, swimming promotes cardiovascular health and mental well-being, offering both physical and emotional benefits. This trial aims to determine whether regular swimming sessions can significantly enhance recovery outcomes compared to traditional methods.

What evidence suggests that swimming might be an effective treatment for post-breast cancer surgery complications?

Research shows that swimming, which participants in the experimental group of this trial will engage in, can help those with complications after breast cancer surgery. Studies have found that water exercises, like swimming, may improve quality of life and reduce symptoms such as swelling in the arms or legs (lymphedema) and fluid buildup (seroma). One study found that 72% of participants who did water exercises experienced no further complications. Another review noted that swimming helps reduce pain and improves shoulder movement in breast cancer survivors. These findings suggest that swimming could be a good option for managing symptoms after surgery. ^{1 2 5 6 7}

Who Is on the Research Team?

Natalie Mills, MD

Principal Investigator

Univeristy of Ottawa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Bruyère Health Research Institute.

Collaborator

University of Ottawa

Collaborator

Trials

231

Recruited

267,000+

Bruyere Research Institute

Collaborator

Trials

35

Recruited

2,024,000+

Published Research Related to This Trial

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]

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12274836/

Effects of aquatic exercises in woman who have ... Aquatic exercises may improve quality of life in patients with breast cancer compared to usual care. Keywords: Aquatic exercise, Breast cancer, ...

2. withpower.com withpower.com/trial/phase-seroma-2022-014a7

Swimming for Post-Breast Cancer Surgery Complications The study on long-term participation in water-exercising after breast cancer surgery found that 72% of participants continued exercising without complications.

3. trialx.com trialx.com/clinical-trials/listings/232971/breaststroke-swimming-after-breast-cancer-treatmentsurgery-as-a-means-of-treatment-for-seroma-lymphedema-and-chronic-arm-and-chest-pain/

Breaststroke Swimming After Breast Cancer Treatment ... Physical activity, in particular swimming, has been linked to improvement in lymphedema/seroma symptoms, but more research is required to ...

4. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/ecc.13535

Systematic review of the effect of aquatic therapeutic ... The objective of this study is to examine the effects of aquatic therapeutic exercise on pain, shoulder mobility, lymphedema, cardiorespiratory ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0003999312009288

The Effectiveness of a Deep Water Aquatic Exercise ... Conclusion. An aquatic exercise program conducted in deep water was effective for improving cancer-related fatigue and strength in breast cancer survivors.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9348687/

Does aquatic physical therapy affect the rehabilitation of ... In conclusion, this meta-analysis confirms that aquatic physical therapy reduces fatigue and improves QoL in women with breast cancer. The high ...

7. clinicaltrial.be clinicaltrial.be/en/details/265237?per_page=100&only_recruiting=0&only_eligible=0

Breaststroke Swimming After Breast Cancer Treatment ... This project will provide crucial knowledge regarding the utility of a simple, swimming based exercise regimen involving the breaststroke in ...