Clinical trial NCT04974268: Reduction of Lymphedema Secondary to Breast Cancer
Official title: Reduction of Lymphedema Secondary to Breast Cancer Through a Structured Exercise and Weight Loss Program. Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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
Lead sponsor: Fundación Pública Andaluza para la Investigación de Málaga en Biomedicina y Salud
Sponsor class: OTHER
First posted: 2021-07-23
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients will be randomized in a 1:1 ratio
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: To assess the change in volume in the limb affected by lymphedema in the intervention group vs control.
timeFrame: Baseline, 3rd and 6th month visits
Secondary outcomes:
measure: BMI (body mass index) changes
timeFrame: Baseline, 3rd and 6th month visits
measure: Change in weight
timeFrame: Baseline, 3rd and 6th month visits
measure: Change in fat free body mass
timeFrame: Baseline, 3rd and 6th month visits
measure: Change in total fat mass
timeFrame: Baseline, 3rd and 6th month visits
measure: Change in water on arm affected by lymphedema
timeFrame: Baseline, 3rd and 6th month visits
measure: Change in water on arm not affected by lymphedema
timeFrame: Baseline, 3rd and 6th month visits
measure: Peripheral muscle strength
timeFrame: Baseline, 3rd and 6th month visits
measure: Level of physical activity (IPAQ questionnaire)
timeFrame: Baseline, 3rd and 6th month visits
measure: Quality of life (through the FACB + 4 test)
timeFrame: Baseline, 3rd and 6th month visits
measure: Change in serum albumin concentration
timeFrame: Baseline, 3rd and 6th month visits
measure: Change in serum prealbumin concentration
timeFrame: Baseline, 3rd and 6th month visits
measure: Change in cholesterol concentration
timeFrame: Baseline, 3rd and 6th month visits
measure: Change in LDL concentration
timeFrame: Baseline, 3rd and 6th month visits
measure: Change in TG concentration
timeFrame: Baseline, 3rd and 6th month visits
measure: Changes in plasma levels of high sensitivity C reactive protein (hs-CRP)
timeFrame: Baseline, 3rd and 6th month visits
measure: Changes in metabolic control
timeFrame: Baseline, 3rd and 6th month visits
measure: Changes in insuline resistance
timeFrame: Baseline, 3rd and 6th month visits
measure: Changes in vitamin D
timeFrame: Baseline, 3rd and 6th month visits
measure: Diet composition
timeFrame: Baseline, 3rd and 6th month visits
Other outcomes:
Locations:
city: Málaga
country: Spain
facility: Hospital Regional Universitario de Málaga
Study officials:
affiliation: Hospital Regional Universitario de Málaga - FIMABIS
name: Gabriel Olveira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: