Breaststroke Swimming After Breast Cancer Treatment/Surgery as a Means of Treatment for Seroma, Lymphedema, and Chronic Arm and Chest Pain

April 4, 2024 updated by: Ottawa Hospital Research Institute
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In 2016, an estimated 25,700 Canadian women were diagnosed with breast cancer. With advances in detection, management and treatment, the 5-year relative survival has improved to 87%. Consequently, breast cancer survivors represent a significant proportion of Canadian society. Research suggests that 30-60 % of women with breast cancer will experience some form of arm morbidity between 6 months and 3 years after breast cancer. Both lymphedema and seroma can cause substantial discomfort, chronic pain, mobility issues, and psychological distress, such as social isolation, anxiety and depression. The current treatment for seroma and lymphedema is drainage, massage, and the use of compression dressings, but these can be ineffective and costly and the effects of the treatment do not last over time. This project will provide crucial knowledge regarding the utility of a simple, swimming based exercise regimen involving the breaststroke in reducing chronic pain related to post-surgical lymphedema or seroma in breast cancer patients. The breaststroke uses a full range of motion in the water, with the water creating a pressure back onto the seroma/damaged tissues. This study will be a randomized, two-arm, pilot study. Patients allocated to the swimming group will participate in 8 weeks of the swimming program, which involves three weekly swimming sessions of 30 minutes minimum. 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. Breast cancer survivors represent a significant proportion of Canadian society, with most recent data suggesting that at least 157,000 Canadian women who had a breast cancer diagnosis in 1999 were still living. Many of these women still suffer from long term complications of their cancer and its treatment. Given the high prevalence of chronic pain in breast cancer survivors, it is unsurprising that the use of pain medications is prevalent as well. A recent U.S. analysis of 10,000 breast cancer patients treated with adjuvant endocrine therapy demonstrated a 56.9% crude probability of opioid use. Within the context of the current opioid crisis in North America, the opportunity to reduce pain and the need for pain medication is absolutely critical.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
128

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada
        • Recruiting
        • University of Ottawa
        • Contact:
          • Monisha Kabir

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Eligible participants include adult female patients, 18 years of age or higher, from the Ottawa Hospital who are post-operative from a lumpectomy or a mastectomy with or without full axillary dissection and radiation. They will be less than 3 years from completion of their acute cancer treatment. Study subjects must have pain symptoms related to chest wall pain and/or arm morbidity, seroma or lymphedema. They must have approval from their medical and radiation oncologist to participate in the study upon enrollment.

Exclusion Criteria:

  • Patients with ongoing medical problems where swimming would be contraindicated will be excluded from this study. Those who swam on a regular basis prior to their breast cancer diagnosis will be excluded from the study, as well as those who cannot swim, due to safety concerns and limited resources/time required to complete more in-depth swimming instruction.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental Group
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.
Behavioral: Swimming
Patients will participate in 8 weeks of the swimming program, which involves three weekly swimming sessions of 30 minutes minimum.
No Intervention: Control Group
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Post-operative pain following breast cancer
Time Frame: The primary measure will be calculated after swimming is completed. This will last approximately 14 months.
The primary outcome will be pain as assessed using a visual analog scale (VAS). The VAS scale is a 100mm-long horizontal line with the word "no pain" at one end and "pain as bad as it can be" at the other. This will be pain levels of patients after the swimming program in comparison with the control group who will receive no swimming program.
The primary measure will be calculated after swimming is completed. This will last approximately 14 months.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Ottawa
Bruyere Research Institute

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Natalie Mills, MD, Univeristy of Ottawa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 21, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 4, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 6, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20190304-01H

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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