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Reduction of Lymphedema Secondary to Breast Cancer (EJERDIETLIF)

Primary Purpose

Lymphedema

Status
Active
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Specific supervised exercise and weight loss program
Sponsored by
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lymphedema focused on measuring Lymphedema, breast cancer, strength training, body composition, body mass index, exercise capacity, health-related quality of life, memory, hypocaloric diet, Mediterranean diet

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Hospital Regional Universitario de Málaga

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Exercise and nutritional program

Control Group

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 23, 2021
Last Updated
February 14, 2023
Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
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1. Study Identification

Unique Protocol Identification Number
NCT04974268
Brief Title
Reduction of Lymphedema Secondary to Breast Cancer
Acronym
EJERDIETLIF
Official Title
Reduction of Lymphedema Secondary to Breast Cancer Through a Structured Exercise and Weight Loss Program. Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 17, 2021 (Actual)
Primary Completion Date
October 14, 2022 (Actual)
Study Completion Date
May 17, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
Keywords
Lymphedema, breast cancer, strength training, body composition, body mass index, exercise capacity, health-related quality of life, memory, hypocaloric diet, Mediterranean diet

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Patients will be randomized in a 1:1 ratio
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise and nutritional program
Arm Type
Experimental
Arm Description
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.
Arm Title
Control Group
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Specific supervised exercise and weight loss program
Intervention Description
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 Outcome Measure Information:
Title
To assess the change in volume in the limb affected by lymphedema in the intervention group vs control.
Description
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.
Time Frame
Baseline, 3rd and 6th month visits
Secondary Outcome Measure Information:
Title
BMI (body mass index) changes
Description
Measured by body composition analysis
Time Frame
Baseline, 3rd and 6th month visits
Title
Change in weight
Description
Weight in kg
Time Frame
Baseline, 3rd and 6th month visits
Title
Change in fat free body mass
Description
Fat free body mass in kg assessed by bioelectrical impedance analysis
Time Frame
Baseline, 3rd and 6th month visits
Title
Change in total fat mass
Description
Total fat mass in kg
Time Frame
Baseline, 3rd and 6th month visits
Title
Change in water on arm affected by lymphedema
Description
Water in ml
Time Frame
Baseline, 3rd and 6th month visits
Title
Change in water on arm not affected by lymphedema
Description
Water in ml
Time Frame
Baseline, 3rd and 6th month visits
Title
Peripheral muscle strength
Description
Measured by hand and quadriceps dynamometry. Assess if strength improves after training.
Time Frame
Baseline, 3rd and 6th month visits
Title
Level of physical activity (IPAQ questionnaire)
Description
Assess whether the level of physical activity improves after training and motivation sessions.
Time Frame
Baseline, 3rd and 6th month visits
Title
Quality of life (through the FACB + 4 test)
Description
Assess if it improves after training and at 6 months of follow-up.
Time Frame
Baseline, 3rd and 6th month visits
Title
Change in serum albumin concentration
Description
Serum albumin in g/dl
Time Frame
Baseline, 3rd and 6th month visits
Title
Change in serum prealbumin concentration
Description
Serum prealbumin in mg/dl
Time Frame
Baseline, 3rd and 6th month visits
Title
Change in cholesterol concentration
Description
Serum cholesterol in mg/dl
Time Frame
Baseline, 3rd and 6th month visits
Title
Change in LDL concentration
Description
Serum LDL in mg/dl
Time Frame
Baseline, 3rd and 6th month visits
Title
Change in TG concentration
Description
Serum TG in mg/dl
Time Frame
Baseline, 3rd and 6th month visits
Title
Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)
Description
Plasma levels of high sensitivity C reactive protein (hs-CRP) in mg/dl
Time Frame
Baseline, 3rd and 6th month visits
Title
Changes in metabolic control
Description
Measured as HbA1c (glycated hemoglobin)
Time Frame
Baseline, 3rd and 6th month visits
Title
Changes in insuline resistance
Description
Measured aas HOMA-IR (homeostatic model assessment of insulin resistance)
Time Frame
Baseline, 3rd and 6th month visits
Title
Changes in vitamin D
Description
Serum vitamin D in ng/ml
Time Frame
Baseline, 3rd and 6th month visits
Title
Diet composition
Description
Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence)
Time Frame
Baseline, 3rd and 6th month visits

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gabriel Olveira, MD, PhD
Organizational Affiliation
Hospital Regional Universitario de Málaga - FIMABIS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Regional Universitario de Málaga
City
Málaga
ZIP/Postal Code
29009
Country
Spain

12. IPD Sharing Statement

Learn more about this trial

Reduction of Lymphedema Secondary to Breast Cancer

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