Reduction of Lymphedema Secondary to Breast Cancer

NCT04974268 | Completed

• 1 other identifier: EJERDIETLINF
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Lymphedema

Keywords

Lymphedema; breast cancer; strength training; body composition; body mass index; exercise capacity; health-related quality of life; memory; hypocaloric diet; Mediterranean diet

Outcome Measures

Primary Outcomes (1)

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

  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.

  Baseline, 3rd and 6th month visits

Secondary Outcomes (19)

• BMI (body mass index) changes

  Baseline, 3rd and 6th month visits

• Change in weight

  Baseline, 3rd and 6th month visits

• Change in fat free body mass

  Baseline, 3rd and 6th month visits

• Change in total fat mass

  Baseline, 3rd and 6th month visits

• Change in water on arm affected by lymphedema

  Baseline, 3rd and 6th month visits

Study Arms (2)

Exercise and nutritional program

EXPERIMENTAL

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.

Other: Specific supervised exercise and weight loss program

Control Group

NO INTERVENTION

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.

Interventions

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.

Exercise and nutritional program

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

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

Study Sites (1)

Hospital Regional Universitario de Málaga

Málaga, Málaga, 29009, Spain

Location

MeSH Terms

Conditions

Lymphedema; Breast Neoplasms

Interventions

Weight Reduction Programs

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Health Promotion; Health Education; Preventive Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Gabriel Olveira, MD, PhD

  Hospital Regional Universitario de Málaga - FIMABIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients will be randomized in a 1:1 ratio

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 23, 2021
• Study Start: May 17, 2021
• Primary Completion: October 14, 2022
• Study Completion: May 17, 2024
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

ES (1)