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

Primary Purpose

Lymphedema, Seroma, Pain, Postoperative

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Swimming
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of OttawaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Experimental Group

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
September 3, 2019
Last Updated
April 14, 2023
Sponsor
Ottawa Hospital Research Institute
Collaborators
University of Ottawa, Bruyere Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT04080934
Brief Title
Breaststroke Swimming After Breast Cancer Treatment/Surgery as a Means of Treatment for Seroma, Lymphedema, and Chronic Arm and Chest Pain
Official Title
Breaststroke Swimming After Breast Cancer Treatment/Surgery as a Means of Treatment for Seroma, Lymphedema, and Chronic Arm and Chest Pain
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
August 21, 2025 (Anticipated)
Study Completion Date
December 31, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
University of Ottawa, Bruyere Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema, Seroma, Pain, Postoperative, Pain, Chest

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
128 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Experimental Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Swimming
Intervention Description
Patients will participate in 8 weeks of the swimming program, which involves three weekly swimming sessions of 30 minutes minimum.
Primary Outcome Measure Information:
Title
Post-operative pain following breast cancer
Description
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.
Time Frame
The primary measure will be calculated after swimming is completed. This will last approximately 14 months.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Natalie Mills, MD
Phone
613-446-6401
Email
dr.nataliemills@rogers.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Natalie Mills, MD
Organizational Affiliation
Univeristy of Ottawa
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Ottawa
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Monisha Kabir

12. IPD Sharing Statement

Plan to Share IPD
No

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

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