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

NCT04080934 | Recruiting

• 1 other identifier: 20190304-01H
• Study Type: interventional
• Target: 128
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Post-operative pain following breast cancer

  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.

Study Arms (2)

Experimental Group

EXPERIMENTAL

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

Control Group

NO 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.

Interventions

Swimming BEHAVIORAL

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

Experimental Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• University of Ottawa: collaborator
• Bruyère Health Research Institute.: collaborator

Study Sites (1)

University of Ottawa

Ottawa, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Lymphedema; Seroma; Pain, Postoperative; Chest Pain

Interventions

Swimming

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Locomotion; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Exercise; Motor Activity

Study Officials

• Natalie Mills, MD

  Univeristy of Ottawa

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Natalie Mills, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2019
• First Posted: September 6, 2019
• Study Start: January 1, 2023
• Primary Completion: August 21, 2025
• Study Completion: December 31, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)