Recruiting

Breaststroke Swimming

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT04080934

Conditions

Lymphedema

Seroma

Pain, Postoperative

Pain, Chest

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Swimming

Study Details

Brief summary:

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.

Conditions

Lymphedema

Seroma

Pain, Postoperative

Pain, Chest

Study ID

NCT04080934

Start date

Jan 1, 2023

Status verified date

Apr, 2024

Completion date

Dec 31, 2025

Anticipated

Primary completion date

Aug 21, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

128 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

Swimming

Patients will participate in 8 weeks of the swimming program, which involves three weekly swimming sessions of 30 minutes minimum.

Primary outcome measure

  • Post-operative pain following breast cancer [ Time Frame: The primary measure will be calculated after swimming is completed. This will last approximately 14 months. ]

Central Contacts and Locations

Central contacts

Natalie Mills, MD

613-446-6401dr.nataliemills@rogers.com

Locations

University of Ottawa

Recruiting

Ottawa, Ontario, Canada

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Apr 5, 2024

Last verified

Apr, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2024-04-05.