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Swimming for Post-Breast Cancer Surgery Complications

N/A

Recruiting

Led By Natalie Mills, MD

Research Sponsored by Ottawa Hospital Research Institute

Eligibility Criteria Checklist

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

Must have

Adult female patients, 18 years of age or higher, from the Ottawa Hospital

Post-operative from a lumpectomy or a mastectomy with or without full axillary dissection and radiation

Timeline

Screening 3 weeks

Treatment Varies

Follow Up the primary measure will be calculated after swimming is completed. this will last approximately 14 months.

Awards & highlights

No Placebo-Only Group

Summary

This trial will study if physical activity, specifically swimming, can reduce post-surgery swelling and fluid build-up that cause pain and reduce quality of life for breast cancer patients.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Swimming generally has low risks but may include muscle soreness or strain. Specific side effects related to this trial haven't been listed but could be associated with individual health conditions that make physical activity challenging.

Eligibility Criteria

Inclusion Criteria

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

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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ the primary measure will be calculated after swimming is completed. this will last approximately 14 months.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~the primary measure will be calculated after swimming is completed. this will last approximately 14 months.

This trial's timeline: 3 weeks for screening, Varies for treatment, and the primary measure will be calculated after swimming is completed. this will last approximately 14 months. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Post-operative pain following breast cancer

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Experimental GroupExperimental Treatment1 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 GroupActive Control1 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.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Swimming

2020

N/A

~120

0 / 2Eligibility criteria met