Clinical Trials Directory

Trials / Recruiting

RecruitingNCT04080934

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

Status
Recruiting
Phase
N/A
Study type
Interventional
Enrollment
128 (estimated)
Sponsor
Ottawa Hospital Research Institute · Academic / Other
Sex
All
Age
18 Years
Healthy volunteers
Not accepted

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.

Conditions

Interventions

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

Timeline

Start date
2023-01-01
Primary completion
2025-08-21
Completion
2025-12-31
First posted
2019-09-06
Last updated
2024-04-05

Locations

1 site across 1 country: Canada

Source: ClinicalTrials.gov record NCT04080934. Inclusion in this directory is not an endorsement.

Breaststroke Swimming After Breast Cancer Treatment/Surgery as a Means of Treatment for Seroma, Lymphedema, and Chronic (NCT04080934) · Clinical Trials Directory