LymphedemaEJERDIETLIFNCT04974268
Reduction of Lymphedema Secondary to Breast Cancer
A study testing Specific supervised exercise and weight loss program in people with Lymphedema, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Lymphedema
- What is being tested?
- Specific supervised exercise and weight loss program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 17 May 2021to 17 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Reduction of Lymphedema Secondary to Breast Cancer Through a Structured Exercise and Weight Loss Program. Randomized Controlled Trial
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.
Read the 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
- Being tested
- Specific supervised exercise and weight loss program
- Keywords
- Lymphedema, breast cancer, strength training, body composition, body mass index, exercise capacity, health-related quality of life, memory, hypocaloric diet, Mediterranean diet
- Medical subject headings
- Lymphedema, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specific supervised exercise and weight loss programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, 3rd and 6th month visits
Secondary outcomes (19)
BMI (body mass index) changes
Measured by body composition analysis
Measured: Baseline, 3rd and 6th month visits
Change in weight
Weight in kg
Measured: Baseline, 3rd and 6th month visits
Change in fat free body mass
Fat free body mass in kg assessed by bioelectrical impedance analysis
Measured: Baseline, 3rd and 6th month visits
Change in total fat mass
Total fat mass in kg
Measured: Baseline, 3rd and 6th month visits
Change in water on arm affected by lymphedema
Water in ml
Measured: Baseline, 3rd and 6th month visits
Change in water on arm not affected by lymphedema
Water in ml
Measured: Baseline, 3rd and 6th month visits
Peripheral muscle strength
Measured by hand and quadriceps dynamometry. Assess if strength improves after training.
Measured: Baseline, 3rd and 6th month visits
Level of physical activity (IPAQ questionnaire)
Assess whether the level of physical activity improves after training and motivation sessions.
Measured: Baseline, 3rd and 6th month visits
Quality of life (through the FACB + 4 test)
Assess if it improves after training and at 6 months of follow-up.
Measured: Baseline, 3rd and 6th month visits
Change in serum albumin concentration
Serum albumin in g/dl
Measured: Baseline, 3rd and 6th month visits
Change in serum prealbumin concentration
Serum prealbumin in mg/dl
Measured: Baseline, 3rd and 6th month visits
Change in cholesterol concentration
Serum cholesterol in mg/dl
Measured: Baseline, 3rd and 6th month visits
Change in LDL concentration
Serum LDL in mg/dl
Measured: Baseline, 3rd and 6th month visits
Change in TG concentration
Serum TG in mg/dl
Measured: Baseline, 3rd and 6th month visits
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
Measured: Baseline, 3rd and 6th month visits
Changes in metabolic control
Measured as HbA1c (glycated hemoglobin)
Measured: Baseline, 3rd and 6th month visits
Changes in insuline resistance
Measured aas HOMA-IR (homeostatic model assessment of insulin resistance)
Measured: Baseline, 3rd and 6th month visits
Changes in vitamin D
Serum vitamin D in ng/ml
Measured: Baseline, 3rd and 6th month visits
Diet composition
Adherence to the Predimed Plus diet pattern 17 (0 - minimum adherence, 17 - maximum adherence)
Measured: Baseline, 3rd and 6th month visits
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2021
- Study start17 May 2021
- Primary completion14 Oct 2022
- Study completion17 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LymphedemaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients will be randomized in a 1:1 ratio
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gabriel Olveira, MD, PhD, Principal investigator, Hospital Regional Universitario de Málaga - FIMABIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04974268
- Sponsor's protocol ID
- EJERDIETLINF
- Acronym
- EJERDIETLIF
- Status last verified
- Feb 2025
- First submitted
- 23 Jun 2021
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Reduction of Lymphedema Secondary to Breast Cancer Through a Structured Exercise and Weight Loss Program. Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04974268
- Acronym / sponsor ID
- EJERDIETLIF / EJERDIETLINF
- Conditions
- Lymphedema
- Keywords
- Lymphedema, breast cancer, strength training, body composition, body mass index, exercise capacity, health-related quality of life, memory
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y SaludUniversity, hospital or other
- Study start
- 17 May 2021 (actual)
- Primary completion
- 14 Oct 2022 (actual)
- Study completion
- 17 May 2024 (actual)
- First posted
- 23 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Patients will be randomized in a 1:1 ratio
| Arm | Type | Receives |
|---|---|---|
| Exercise and nutritional program | Experimental | Other: Specific supervised exercise and weight loss programIntervention 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 | 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Specific supervised exercise and weight loss programIntervention 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. | Other | Exercise and nutritional program |
Primary outcome
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.
19 secondary outcomes
BMI (body mass index) changes
Time frame: Baseline, 3rd and 6th month visits
Change in weight
Time frame: Baseline, 3rd and 6th month visits
Change in fat free body mass
Time frame: Baseline, 3rd and 6th month visits
Change in total fat mass
Time frame: Baseline, 3rd and 6th month visits
Change in water on arm affected by lymphedema
Time frame: Baseline, 3rd and 6th month visits
Change in water on arm not affected by lymphedema
Time frame: Baseline, 3rd and 6th month visits
Peripheral muscle strength
Time frame: Baseline, 3rd and 6th month visits
Level of physical activity (IPAQ questionnaire)
Time frame: Baseline, 3rd and 6th month visits
Quality of life (through the FACB + 4 test)
Time frame: Baseline, 3rd and 6th month visits
Change in serum albumin concentration
Time frame: Baseline, 3rd and 6th month visits
Change in serum prealbumin concentration
Time frame: Baseline, 3rd and 6th month visits
Change in cholesterol concentration
Time frame: Baseline, 3rd and 6th month visits
Change in LDL concentration
Time frame: Baseline, 3rd and 6th month visits
Change in TG concentration
Time frame: Baseline, 3rd and 6th month visits
Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)
Time frame: Baseline, 3rd and 6th month visits
Changes in metabolic control
Time frame: Baseline, 3rd and 6th month visits
Changes in insuline resistance
Time frame: Baseline, 3rd and 6th month visits
Changes in vitamin D
Time frame: Baseline, 3rd and 6th month visits
Diet composition
Time frame: Baseline, 3rd and 6th month visits
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gabriel Olveira, MD, PhD principal investigator
Hospital Regional Universitario de Málaga - FIMABIS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Specific supervised exercise and weight loss program in people with Lymphedema, run by Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2025.