Reduction of Lymphedema Secondary to Breast Cancer

NCT ID: NCT04974268

Last Updated: 2025-02-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-17
• Study Completion Date: 2024-05-17

Brief 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.

Detailed 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.

Conditions

Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Exercise and nutritional program

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 (non-mandatory), manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.

Group Type: EXPERIMENTAL

Specific supervised exercise and weight loss program

Intervention Type: 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.

Control Group

Control group will receive recommendations for aerobic unsupervised exercise 150 min per week, standard dietary recommendations (Mediterranean diet pattern and 1800 Kcal diet), manual lymphatic drainage and compression garment if there is more than 600 ml of excess volume in the limb affected.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Specific supervised exercise and weight loss program

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

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

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gabriel Olveira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Regional Universitario de Málaga - FIMABIS

Locations

Hospital Regional Universitario de Málaga

Málaga, Málaga, Spain

Countries

Spain

Other Identifiers

EJERDIETLINF

Identifier Type: -

Identifier Source: org_study_id