We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04080934
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : April 18, 2023
Sponsor:
Collaborators:
University of Ottawa
Bruyere Research Institute
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Tracking Information
First Submitted Date  ICMJE September 3, 2019
First Posted Date  ICMJE September 6, 2019
Last Update Posted Date April 18, 2023
Actual Study Start Date  ICMJE January 1, 2023
Estimated Primary Completion Date August 21, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 4, 2019)		 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Breaststroke Swimming After Breast Cancer Treatment/Surgery as a Means of Treatment for Seroma, Lymphedema, and Chronic Arm and Chest Pain
Official Title  ICMJE Breaststroke Swimming After Breast Cancer Treatment/Surgery as a Means of Treatment for Seroma, Lymphedema, and Chronic Arm and Chest Pain
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Lymphedema
  • Seroma
  • Pain, Postoperative
  • Pain, Chest
Intervention  ICMJE Behavioral: Swimming
Patients will participate in 8 weeks of the swimming program, which involves three weekly swimming sessions of 30 minutes minimum.
Study Arms  ICMJE
  • 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.
    Intervention: Behavioral: Swimming
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 4, 2019)		 128
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date August 21, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Natalie Mills, MD 613-446-6401 dr.nataliemills@rogers.com
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04080934
Other Study ID Numbers  ICMJE 20190304-01H
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Ottawa Hospital Research Institute
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Ottawa Hospital Research Institute
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • University of Ottawa
  • Bruyere Research Institute
Investigators  ICMJE
Principal Investigator: Natalie Mills, MD Univeristy of Ottawa
PRS Account Ottawa Hospital Research Institute
Verification Date May 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP