Lymphatic Response to Resistance Exercise in Breast Cancer Survivors

NCT06113627 | Not Yet Recruiting

• 1 other identifier: 10-2023
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer Lymphedema; Survivorship; Lymphedema of Upper Limb

Keywords

Breast Cancer; Lymphedema, Early-Onset; Breast Cancer Lymphedema; Exercise Therapy; Exercise Training; Acute Exercise; Exercise Movement Techniques; Physiotherapy (Techniques)

Outcome Measures

Primary Outcomes (1)

• Changes in volume difference between extremities (%)

  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.

  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

Secondary Outcomes (11)

• Changes in extracelular fluid (ECF)

  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

• Changes in Percentage Water Content (PWC)

  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

• Changes in Thickness of the dermis and subdermis

  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

• Changes in echogenicity of the dermis and subdermis

  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

• Changes in elastic properties of tissues.

  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

Study Arms (2)

Exercise group

EXPERIMENTAL

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.

Other: Resistance Therapeutic Exercise

Control group

NO INTERVENTION

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.

Interventions

Resistance Therapeutic Exercise OTHER

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.

Exercise group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Malaga: lead

Study Sites (1)

Cristina Roldán Jiménez

Málaga, Spain

Location

Related Publications (7)

• Roldán-Jiménez C. What are the physiologic effects of Resistance Exercise behind breast cancer-related lymphedema prevention? Medical Hypotheses Volume 171, February 2023, 111022. https://doi.org/10.1016/j.mehy.2023.111022

  BACKGROUND

• Roldan-Jimenez C, Pajares B, Ruiz-Medina S, Trinidad-Fernandez M, Gonzalez-Sanchez M, Ribelles N, Garcia-Almeida JM, Rios-Lopez MJ, Alba E, Cuesta-Vargas AI. Design and implementation of a standard care programme of therapeutic exercise and education for breast cancer survivors. Support Care Cancer. 2022 Feb;30(2):1243-1251. doi: 10.1007/s00520-021-06470-9. Epub 2021 Aug 31.

  PMID: 34463835 BACKGROUND

• Gutierrez-Sanchez D, Pajares-Hachero BI, Trinidad-Fernandez M, Escriche-Escuder A, Iglesias-Campos M, Bermejo-Perez MJ, Alba-Conejo E, Roldan-Jimenez C, Cuesta-Vargas A. The Benefits of a Therapeutic Exercise and Educational Intervention Program on Central Sensitization Symptoms and Pain-Related Fear Avoidance in Breast Cancer Survivors. Pain Manag Nurs. 2022 Aug;23(4):467-472. doi: 10.1016/j.pmn.2022.01.003. Epub 2022 Mar 9.

  PMID: 35277360 BACKGROUND

• Roldan-Jimenez C, Martin-Martin J, Pajares B, Ribelles N, Alba E, Cuesta-Vargas AI. Factors associated with upper limb function in breast cancer survivors. PM R. 2023 Feb;15(2):151-156. doi: 10.1002/pmrj.12731. Epub 2021 Nov 23.

  PMID: 34713595 BACKGROUND

• Escriche-Escuder A, Trinidad-Fernandez M, Pajares B, Iglesias-Campos M, Alba E, Cuesta-Vargas AI, Roldan-Jimenez C. Ultrasound use in metastatic breast cancer to measure body composition changes following an exercise intervention. Sci Rep. 2021 Apr 23;11(1):8858. doi: 10.1038/s41598-021-88375-5.

  PMID: 33893370 BACKGROUND

• Davies C, Levenhagen K, Ryans K, Perdomo M, Gilchrist L. Interventions for Breast Cancer-Related Lymphedema: Clinical Practice Guideline From the Academy of Oncologic Physical Therapy of APTA. Phys Ther. 2020 Jul 19;100(7):1163-1179. doi: 10.1093/ptj/pzaa087.

  PMID: 32589208 BACKGROUND

• Wang L, Shi YX, Wang TT, Chen KX, Shang SM. Breast cancer-related lymphoedema and resistance exercise: An evidence-based review of guidelines, consensus statements and systematic reviews. J Clin Nurs. 2023 May;32(9-10):2208-2227. doi: 10.1111/jocn.16437. Epub 2022 Jul 27.

  PMID: 35894167 BACKGROUND

MeSH Terms

Conditions

Breast Cancer Lymphedema; Breast Neoplasms; Lymphedema

Condition Hierarchy (Ancestors)

Lymphatic Diseases; Hemic and Lymphatic Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Blinding of the researchers in charge of the evaluations and data analysis will be implemented, so that they are unaware of the assignment of each patient to the groups. It is not possible to blind participants and the physiotherapist (care provider) due to the very nature of the intervention
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Profesor and Reseacher (PT, PhD)

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: October 9, 2023
• First Posted: November 2, 2023
• Study Start: August 1, 2024
• Primary Completion: July 15, 2025
• Study Completion (Estimated): January 15, 2027
• Last Updated: November 2, 2023

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)