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Completed

NCT Number: NCT04974268

Reduction of Lymphedema Secondary to Breast Cancer

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.

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Key information

Age range

18 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Regional Universitario de Málaga

Málaga, 29009, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 2 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 higher than 35.
  • 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.

Treatment and study plan

Specific supervised exercise and weight loss program

Other

Intervention group that receives supervised exercise and weight loss program based on individual and group intervention with Mediterranean diet and substitute for a daily meal, manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.

Primary outcomes

  1. To assess the change in volume in the limb affected by lymphedema in the intervention group vs control.

    Time frame: Baseline, 3rd and 6th month visits

    It will be studied whether a reduction of 200 ml of the affected arm is achieved with respect to itself and / or with respect to the healthy one, after training.

Secondary outcomes

  1. BMI (body mass index) changes

    Time frame: Baseline, 3rd and 6th month visits

    Measured by body composition analysis

  2. Change in weight

    Time frame: Baseline, 3rd and 6th month visits

    Weight in kg

  3. Change in fat free body mass

    Time frame: Baseline, 3rd and 6th month visits

    Fat free body mass in kg assessed by bioelectrical impedance analysis

  4. Change in total fat mass

    Time frame: Baseline, 3rd and 6th month visits

    Total fat mass in kg

  5. Change in water on arm affected by lymphedema

    Time frame: Baseline, 3rd and 6th month visits

    Water in ml

  6. Change in water on arm not affected by lymphedema

    Time frame: Baseline, 3rd and 6th month visits

    Water in ml

  7. Peripheral muscle strength

    Time frame: Baseline, 3rd and 6th month visits

    Measured by hand and quadriceps dynamometry. Assess if strength improves after training.

  8. Level of physical activity (IPAQ questionnaire)

    Time frame: Baseline, 3rd and 6th month visits

    Assess whether the level of physical activity improves after training and motivation sessions.

  9. Quality of life (through the FACB + 4 test)

    Time frame: Baseline, 3rd and 6th month visits

    Assess if it improves after training and at 6 months of follow-up.

  10. Change in serum albumin concentration

    Time frame: Baseline, 3rd and 6th month visits

    Serum albumin in g/dl

  11. Change in serum prealbumin concentration

    Time frame: Baseline, 3rd and 6th month visits

    Serum prealbumin in mg/dl

  12. Change in cholesterol concentration

    Time frame: Baseline, 3rd and 6th month visits

    Serum cholesterol in mg/dl

  13. Change in LDL concentration

    Time frame: Baseline, 3rd and 6th month visits

    Serum LDL in mg/dl

  14. Change in TG concentration

    Time frame: Baseline, 3rd and 6th month visits

    Serum TG in mg/dl

  15. Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)

    Time frame: Baseline, 3rd and 6th month visits

    Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl

  16. Changes in metabolic control

    Time frame: Baseline, 3rd and 6th month visits

    Measured as HbA1c (glycated hemoglobin)

  17. Changes in insuline resistance

    Time frame: Baseline, 3rd and 6th month visits

    Measured aas HOMA-IR (homeostatic model assessment of insulin resistance)

  18. Changes in vitamin D

    Time frame: Baseline, 3rd and 6th month visits

    Serum vitamin D in ng/ml

  19. Diet composition

    Time frame: Baseline, 3rd and 6th month visits

    Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence)

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

Other

Registry information

Official study title

Reduction of Lymphedema Secondary to Breast Cancer Through a Structured Exercise and Weight Loss Program. Randomized Controlled Trial

Acronym: EJERDIETLIF

Important dates

Study start
2021
Primary completion
2022
Study completion
2024
First posted
Jul 23, 2021
Registry last updated
Feb 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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