Lymphatic Response to Resistance Exercise in Breast Cancer Survivors

NCT06113627 · tracked via the Priya Life Science Spain tracker

Sponsor

University of Malaga

Phase

Not applicable

Started

2024-08

Last updated

2023-11-02

Condition(s) studied

Breast Cancer LymphedemaSurvivorshipLymphedema of Upper Limb

Investigational drug(s) / intervention(s)

Resistance Therapeutic Exercise

Resistance Therapeutic Exercise: Strength exercises will be aimed at large muscle groups, such as the shoulder, chest, back and also muscle groups of the lower extremities. In the initial 2 weeks, intervention will start with low intensities of around 55-65% of 1RM, which allows to perform around 15-20 repetitions. The first week there will be performed 2 series, while in the second week it will be 3 series. Moderate intensity in the 2nd week, corresponding to 65-75% of 1RM and allowing for around 8-12 repetitions. 3 series will be maintained throughout this period of time.In addition to the progressive change in intensity, throughout the intervention the load will be increased by 5-10% when the patient performs the exercise too easily or when they can perform more repetitions than estimated. Rest between sets will be 2-3 minutes.

Study summary

The objective of this study is 1) to study the acute and chronic effect of resistance therapeutic physical exercise (RTPE) in the prevention of breast cancer-related lymphedema (BCRL) in breast cancer survivors at risk using variables related to the lymphatic response; 2) Study the possible relationship between changes in body composition at a local and regional level and volume changes produced by RTPE in patients at risk of suffering from BCRL.

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

—

Healthy volunteers

Inclusion Criteria: * Women diagnosed with breast cancer * Being of legal age * Histologically confirmed primary Breast Cancer (I-IIIA) (without the presence of metastasis) with a diagnosis in the last year * Unilateral involvement * Surgery for the tumor at least 6 weeks before the start of the intervention * WHO performance status of 0 (asymptomatic, complete and ambulatory activity) * Correct understanding of Spanish * Approval by signing the informed consent; * Mus be considered at risk for developing LACM: 1) Have undergone surgery that includes axillary dissection; 2) Have received or are undergoing regional lymph node radiation; 3) BMI \>30 kg/m2. . These patients are considered to have stage 0, subclinical or latent according to the International Society of Lymphology (ISL) , since they will not present signs or symptoms, but lymphatic transport will be altered by the treatments themselves Exclusion Criteria: * Women already diagnosed with LACM in stage I, II or III according to the ISL or if they present an L-Dex ratio \> 10 or a difference in volume equal to or greater than 10% between both extremities * Suffer from or have been diagnosed with any other lymphatic-venous disease in the upper extremity, such as venous insufficiency, thrombosis or lipedema; * Suffer from conditions that prevent resistance exercise of the upper body * Participation in regular (\>1 time/week) and intense exercises involving the upper extremity during the last month * Suffer from heart disease * Inability to complete questionnaires; * A physical condition that prevents them from making hospital visits * Taking any drug that may affect the lymphatic and circulatory system, such as diuretics or corticosteroids * Women which presents some type of wound or infection on the skin.

Primary outcome measure(s)

Changes in volume difference between extremities (%) — Six measures: Baseline, before and 24 hours after the day 5 of exercise session, before and 24 hours after the 24 day of exercise session; after 3 month once completed the whole intervention, and after 1 year
The volume of both extremities will be measured to obtain the difference between both, which will be used as a relative criterion to determine the preventive effect of the intervention, determining the appearance of LACM as those cases in which the patient reaches a difference after one year of follow-up. volume equal to or greater than 10% between both extremities. It will be measured using water displacement volumetry, considered the gold standard for measuring the volume of the affected limb.

Trial sites (1)

Facility	City	Region	Status
Cristina Roldán Jiménez	Málaga	Spain

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06113627 on ClinicalTrials.gov ↗ ← All trials in Spain