Clinical trial NCT06491654: Physiotherapy Program Impact on Breast Cancer-Related Lymphedema
Official title: Effect of a Physiotherapy Program Based on Concurrent Strength and Moderate-to-high Intensity Aerobic Exercise Training, Along With Cohesive Bandaging, in Women With Breast Cancer-related Lymphedema.
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Breast Cancer Related Lymphedema
Keywords: High-intensity functional training
Breast cancer
Lymphedema
Compression bandage
Strength exercise
Quality of life
Lead sponsor: European University Miguel de Cervantes
Sponsor class: OTHER
Collaborators: name: Hospital Clínico Universitario de Valladolid
First posted: 2024-07-09
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective single-center randomized clinical trial.
Primary purpose: TREATMENT

Brief summary: Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection and regional lymph node radiation. The main objective of the present clinical trial is to determine the effectiveness of moderate-high intensity strength training in combination with an aerobic exercise protocol and the application of cohesive compression bandaging in subjects with or at risk for BCRL and to analyze the acute responses of the molecular, functional and clinical profile of patients with BCRL or at risk after two sessions of intervention. To compare proteomic analysis of patients or at risk with healthy controls and to assess the adaptations produced after 12 weeks of exercise intervention and over a 12-week post-intervention period in patients with BCRL or at risk.

Detailed description: Breast Cancer Related Lymphedema (BCRL) is a sequela resulting from the application of certain treatments, such as axillary lymph node dissection andregional lymph node radiation. Clinically, it can cause pain, swelling and a decrease in the functionality of those patients who suffer from it. Moderate-high intensity strength exercise, in combination with aerobic exercise and a cohesive compressive bandage, could minimize the associated symptomatology and clinical symptoms, as well as improve various biological parameters related to tumor progression and increase the functionality of patients. Likewise, the study of the long-term effects of the treatment will make it possible to determine the chronic adaptations generated by exercise.

The intervention will consist of concurrent training (strength and aerobic exercise) for all patients, whether they have BCRL or are at risk. Also, patients with BCRL will have cohesive bandaging applied at the end of the exercise session. The main objective of this study is to determine the benefits that moderate-high intensity strength training, in combination with an aerobic exercise protocol and, together with the application of a compressive bandage, generates on patients suffering from BCRL or at risk of suffering it. Through this investigation, we seek to analyze the impact of the intervention on various clinical, functional, and molecular factors. Likewise, healthy controls participants will participate in two exercise interventions and functional and molecular adaptations will be analyzed.

Eligibility criteria: Inclusion Criteria:

* Breast cancer survivors who have completed treatment (chemotherapy, surgery, and/or radiotherapy) at least 6 months prior to randomization for the trial.
* Patients diagnosed with unilateral stage I or II BCRL as established by the International Society of Lymphology Congress Working Group in 2020, or patients at risk of developing unilateral BCRL (who have received radiotherapy in the axillary region/radical mastectomy/modified radical mastectomy and lymph node dissection/breast surgery and sentinel lymph node biopsy).
* Age between 18 and 65 years.
* Voluntary participation in the study and informed consent.

Exclusion Criteria:

* Recent surgery (\<3 months) or planned surgery during the study period.
* Patients with cognitive impairment.
* Patients with bilateral lymphedema.
* Health problems or illnesses that prevent them from participating in the intervention.
* Other serious conditions that may affect their HRQOL (Health-Related Quality of Life).

Primary outcomes:
measure: Molecular variables: proteome.
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: total session workload and total workload.
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: physical activity levels
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: upper limb strength.
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: lower limb strength.
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: manual grip strength.
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: endurance and effort intensity
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: blood pressure
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: gas consumption analysis
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: endurance and effort intensity.
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: Heart rate.
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: Rate of perceived exertion (RPE)
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: Electrical activity released by muscles by electromyography with surface electrodes to analyze muscle response.
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Functional variables: Electrical activity released by muscles by electromyography with surface electrodes to analyze electrical activity.
timeFrame: 0 weeks, 1 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Health-related quality of life by Functional Assessment of Cancer Therapy Questionnaire for Breast Cancer (FACT-B and FACT-b+4).
timeFrame: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Health-related quality of life by Upper Limb Lymphedema (ULL)-27 Questionnaire.
timeFrame: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Disabilities of the Arm, Shoulder and Hand (DASH) Questionnaire.
timeFrame: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Numeric Rating Scale (NRS).
timeFrame: 0 weeks, 6 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Blood pressure.
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Arm-ankle index
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Flow-mediated dilation of the brachial artery.
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Ankle-brachial index.
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Arm volume.
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Range of joint motion.
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Heart rate variability.
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Ultrasound assessment of lymphedema.
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Echocardiographic measurement.
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Bone mineral density.
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
measure: Clinical variables: Body composition.
timeFrame: 0 weeks, 1 weeks, 12 weeks, 24 weeks.
Secondary outcomes:
Other outcomes:
Locations:
city: Valladolid
country: Spain
facility: European University Miguel of Cervantes
state: Castilla y León
Study officials:
affiliation: Universidad Europea Miguel de Cervantes
name: Alejandro Santos Lozano, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Executive Committee of the International Society of Lymphology. The diagnosis and treatment of peripheral lymphedema: 2020 Consensus Document of the International Society of Lymphology. Lymphology. 2020;53(1):3-19.