Reduction of Lymphedema Secondary to Breast Cancer

  • STATUS
    Recruiting
  • End date
    May 17, 2024
  • participants needed
    100
  • sponsor
    Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Updated on 22 September 2021
drainage
cancer
breast cancer
compression therapy

Summary

This study evaluates the reduction of lymphedema and its complications in obese women treated with a muscle training and weight loss program as well as the improvement body composition, muscle strength, quality of life and neurocognitive function, compared to a conventional treatment control group.

Description

Introduction: Breast cancer is the most frequent tumour in women. Breast cancer-related lymphedema (BCRL) occurs in 10 to 36% of patients undergoing dissection and emptying of axillary nodes and between 5 and 17% undergoing sentinel node biopsy. BCRL is associated with discomfort, pain, risk of infections, disability, symptoms of depression and anxiety and worse quality of life. The prevalence of persistent lymphedema increases with the presence of obesity.

Aim: In overweight or obese women with BCRL to assess whether a muscle training and weight loss program reduces lymphedema volume and its associated complications, as well as improves body composition, muscle strength, quality of life and neurocognitive function, compared to a conventional treatment control group.

Methodology: Open prospective randomized trial of 2 parallel arms. Subjects: patients referred to the Rehabilitation Unit with lymphedema secondary to breast cancer and overweight or obesity. The control group will receive the usual treatment and general dietary recommendations and the intervention group will carry out a program of supervised exercise (strength and aerobic) and weight loss (based on the Mediterranean diet and with a meal replacement). The change in volume in the limb affected by lymphedema, segmental body composition and phase angle (impedance measurement), muscular strength (hand dynamometry), level of physical activity (IPAQ), dietary parameters, quality of life (FACB+4) will be assessed. Cognitive function (Memory FSRCT test), psychological symptoms (anxiety and depression by means of HADS) NS biochemical parameters (albumin, prealbumin, lipids, CRP, 25-OH vitamin D and insulin) will be analyzed.

Details
Condition Lymphedema, lymphoedema
Treatment Specific supervised exercise and weight loss program
Clinical Study IdentifierNCT04974268
SponsorFundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Last Modified on22 September 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Patients older than 18 years and under 80 who have lymphedema diagnosed according to the truncated cone formula (increase of > 200 ml with respect to the contralateral) and are referred to Rehabilitation for treatment
Having completed the chemotherapy and radiotherapy treatment at least 6 months prior to randomization
Not having received manual lymphatic drainage in the 6 months prior to the intervention
BMI > 25 y < 40 kg/m2
Signature of informed consent

Exclusion Criteria

Traumatological, neurological, rheumatological or cardiovascular problems that prevent patients from performing the training
Phase IIIB structured lymphedema
Metastatic disease
Illness that prevents the subject from carrying out the program
Unstable heart disease
Ejection fraction of the left ventricle less than 50
Voluntary or involuntary weight loss > 10% in the last 3 months
Illiterate
Those who do not sign the informed consent to participate in the study
Abusive intake of alcohol or other dependencies that in the opinion of the investigator could interfere with the study
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