Lymphatic Response to Resistance Exercise in Breast Cancer Survivors (LinfoGYM)

University of Malaga

Status: Not yet enrolling

Conditions: Breast Cancer Lymphedema; Lymphedema of Upper Limb; Survivorship

Treatments: Other: Resistance Therapeutic Exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT06113627

10-2023

Details and patient eligibility

About

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.

Full description

Nowadays, research studies that confirm the safety and preventive effect of resistance or strength exercise in breast cancer-related lymphedema (BCRL) have been limited to the study of changes in variables related to the lymphatic response, such as bioimpedance spectroscopy , X-ray absorptiometry, perometry or water displacement after completion of a resistance exercise program (chronic effect).

To better understand the preventive effect of resistance exercise on the BCRL, in addition to studying the variables that are globally accepted and studied at a regional level such as the volume due to water displacement, variables that measure changes at a regional level related to body composition, such as such as echogenicity and ultrasound thickness, local tissue water and mechanical properties of tissues. Furthermore, this would allow us to detect possible changes in different body regions of the upper quadrant (upper extremity, but also breast or back), and not only taking global changes into account. On the other hand, the lymphatic response should be studied in the short term (acute effect), in the long term after an exercise program (chronic effect), as well as in the short term after the training period with possible adaptations to the lymphatic system that could explain the preventive effect.

Therefore, although there is a strong degree of scientific evidence to include therapeutic strength physical exercise as a preventive tool for LACM, the possible physiological mechanisms involved are unknown. The aim of the present project is to tudy 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 regional but also local variables related to the lymphatic response, as well as to study between changes in these variables, body composition at a local and regional level and volume changes produced by RTPE in breast cancer survivors at risk of suffering from BCRL

Enrollment: 170 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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170 participants in 2 patient groups

Exercise group

Experimental group

Description:

The intervention group will receive a total of 24 sessions of Therapeutic Resistance Exercise, distributed in 2 weekly sessions of 50 minutes during 3 months.

Treatment:

Other: Resistance Therapeutic Exercise

Control group

No Intervention group

Description:

The control group will receive an educational booklet containing generalized mobility exercises such as frontal and lateral shoulder raises and rotations (hands to head, hands behind back). This is usually the usual treatment, since in most centers, patients are only referred for treatment of LACM when it is already established.