Status:
NOT_YET_RECRUITING
Lymphatic Response to Resistance Exercise in Breast Cancer Survivors
Lead Sponsor:
University of Malaga
Conditions:
Breast Cancer Lymphedema
Survivorship
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The objective of this study is 1) to study the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer...
Detailed Description
Nowadays, research studies that confirm the safety and preventive effect of resistance or strength exercise in breast cancer-related lymphedema (BCRL) have been limited to the study of changes in vari...
Eligibility Criteria
Inclusion
- Women diagnosed with breast cancer
- Being of legal age
- Histologically confirmed primary Breast Cancer (I-IIIA) (without the presence of metastasis) with a diagnosis in the last year
- Unilateral involvement
- Surgery for the tumor at least 6 weeks before the start of the intervention
- WHO performance status of 0 (asymptomatic, complete and ambulatory activity)
- Correct understanding of Spanish
- Approval by signing the informed consent;
- Mus be considered at risk for developing LACM: 1) Have undergone surgery that includes axillary dissection; 2) Have received or are undergoing regional lymph node radiation; 3) BMI \>30 kg/m2. . These patients are considered to have stage 0, subclinical or latent according to the International Society of Lymphology (ISL) , since they will not present signs or symptoms, but lymphatic transport will be altered by the treatments themselves
Exclusion
- Women already diagnosed with LACM in stage I, II or III according to the ISL or if they present an L-Dex ratio \> 10 or a difference in volume equal to or greater than 10% between both extremities
- Suffer from or have been diagnosed with any other lymphatic-venous disease in the upper extremity, such as venous insufficiency, thrombosis or lipedema;
- Suffer from conditions that prevent resistance exercise of the upper body
- Participation in regular (\>1 time/week) and intense exercises involving the upper extremity during the last month
- Suffer from heart disease
- Inability to complete questionnaires;
- A physical condition that prevents them from making hospital visits
- Taking any drug that may affect the lymphatic and circulatory system, such as diuretics or corticosteroids
- Women which presents some type of wound or infection on the skin.
Key Trial Info
Start Date :
August 1 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 15 2027
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT06113627
Start Date
August 1 2024
End Date
January 15 2027
Last Update
November 2 2023
Active Locations (1)
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1
Cristina Roldán Jiménez
Málaga, Spain