Reduction of Lymphedema Secondary to Breast Cancer

Lymphedema Clinical Trial

— EJERDIETLIF  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04974268
• Other study ID #: EJERDIETLINF
• Status: Active, not recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: May 17, 2024

Study information

• Verified date: April 2022
• Source: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: May 17, 2024
• Est. primary completion date: October 14, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lymphedema

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Spain	Hospital Regional Universitario de Málaga	Málaga

Sponsors (1)

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

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	BMI (body mass index) changes	Measured by body composition analysis	Baseline, 3rd and 6th month visits
Secondary	Change in weight	Weight in kg	Baseline, 3rd and 6th month visits
Secondary	Change in fat free body mass	Fat free body mass in kg assessed by bioelectrical impedance analysis	Baseline, 3rd and 6th month visits
Secondary	Change in total fat mass	Total fat mass in kg	Baseline, 3rd and 6th month visits
Secondary	Change in water on arm affected by lymphedema	Water in ml	Baseline, 3rd and 6th month visits
Secondary	Change in water on arm not affected by lymphedema	Water in ml	Baseline, 3rd and 6th month visits
Secondary	Peripheral muscle strength	Measured by hand and quadriceps dynamometry. Assess if strength improves after training.	Baseline, 3rd and 6th month visits
Secondary	Level of physical activity (IPAQ questionnaire)	Assess whether the level of physical activity improves after training and motivation sessions.	Baseline, 3rd and 6th month visits
Secondary	Quality of life (through the FACB + 4 test)	Assess if it improves after training and at 6 months of follow-up.	Baseline, 3rd and 6th month visits
Secondary	Change in serum albumin concentration	Serum albumin in g/dl	Baseline, 3rd and 6th month visits
Secondary	Change in serum prealbumin concentration	Serum prealbumin in mg/dl	Baseline, 3rd and 6th month visits
Secondary	Change in cholesterol concentration	Serum cholesterol in mg/dl	Baseline, 3rd and 6th month visits
Secondary	Change in LDL concentration	Serum LDL in mg/dl	Baseline, 3rd and 6th month visits
Secondary	Change in TG concentration	Serum TG in mg/dl	Baseline, 3rd and 6th month visits
Secondary	Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)	Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl	Baseline, 3rd and 6th month visits
Secondary	Changes in metabolic control	Measured as HbA1c (glycated hemoglobin)	Baseline, 3rd and 6th month visits
Secondary	Changes in insuline resistance	Measured aas HOMA-IR (homeostatic model assessment of insulin resistance)	Baseline, 3rd and 6th month visits
Secondary	Changes in vitamin D	Serum vitamin D in ng/ml	Baseline, 3rd and 6th month visits
Secondary	Diet composition	Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence)	Baseline, 3rd and 6th month visits