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Search / Trial NCT06113627

Lymphatic Response to Resistance Exercise in Breast Cancer Survivors

Launched by UNIVERSITY OF MALAGA · Oct 30, 2023

Trial Information

Current as of June 26, 2025

Not yet recruiting

Keywords

Breast Cancer Lymphedema, Early Onset Breast Cancer Lymphedema Exercise Therapy Exercise Training Acute Exercise Exercise Movement Techniques Physiotherapy (Techniques)

ClinConnect Summary

This clinical trial is examining how resistance exercise can impact breast cancer survivors who are at risk of developing lymphedema, a condition that causes swelling in the arms. The study aims to see both the immediate and long-term effects of this type of exercise on the lymphatic system, which helps to manage fluid in the body. Researchers will also look at how changes in body composition might relate to any changes in arm volume as a result of the exercise.

To participate in this study, women must be diagnosed with breast cancer within the last year and have had surgery for their tumor at least six weeks before starting. They should also be considered at risk for lymphedema, which may be due to specific surgeries or treatments they have received. Participants will need to understand Spanish and be able to sign a consent form. If eligible, they can expect to engage in a structured exercise program while being monitored for any potential effects on their arm swelling. It's important to know that some women, such as those already diagnosed with lymphedema or certain other health conditions, will not be able to participate. Overall, this study could provide valuable insights into how exercise might help improve the health and quality of life for breast cancer survivors.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 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 Criteria:
  • 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.

About University Of Malaga

The University of Malaga, a leading academic institution in Spain, is committed to advancing medical research and improving patient outcomes through innovative clinical trials. With a focus on interdisciplinary collaboration, the university leverages its extensive resources and expertise in various fields, including medicine, health sciences, and biotechnology, to conduct rigorous studies. The institution is dedicated to fostering a culture of ethical research practices and ensuring the highest standards of safety and efficacy in its clinical trials, ultimately contributing to the development of groundbreaking therapies and enhancing the overall quality of healthcare.

Locations

Málaga, , Spain

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported