Physiotherapy Program Impact on Breast Cancer-Related Lymphedema

NCT ID: NCT06491654

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: SUSPENDED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-11
• Study Completion Date: 2025-10-10

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.

Conditions

Breast Cancer Related Lymphedema

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Lymphedema experimental

Subjects belonging to this group perform a 12-week supervised exercise. The patients will follow a moderate-to-high intensity strength exercise protocol, along with the application of a cohesive bandage (bandage will only be applied in subjects with Breast Cancer-Related Lymphedema, BCRL, and not in patients at risk).

Group Type: EXPERIMENTAL

12-week supervised exercise

Intervention Type: OTHER

During the study period (1 week for acute effects, 12 weeks for chronic effects), there will be 8 sessions per month, lasting 40-60 minutes each, with 2 sessions per week on alternate days, totaling 24 sessions. Each session includes: (1) warm-up (mobility exercises); (2) training: 5-min warm-up, followed by 15-min moderate-to-high intensity circuit of 7 functional global exercises with 10 reps each at a perceived exertion effort (RPE) of 5-7 on a scale of 1 to 10; (3) Aerobic exercise: starting at 15 mins, increasing by 5 mins biweekly to 30 mins by week 7; (4) Cool-down (general mobility); (5) Application of cohesive compressive bandage on the affected upper limb, worn for 2 hours post-session, removed at home. Participants may add a cotton bandage and finger bandage if needed.

Healthy control

Subjects belonging to this group perform a 1-week supervised exercise, following the same training protocol as experimental group (arm 1). This group will not receive cohesive compressive bandage.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

12-week supervised exercise

During the study period (1 week for acute effects, 12 weeks for chronic effects), there will be 8 sessions per month, lasting 40-60 minutes each, with 2 sessions per week on alternate days, totaling 24 sessions. Each session includes: (1) warm-up (mobility exercises); (2) training: 5-min warm-up, followed by 15-min moderate-to-high intensity circuit of 7 functional global exercises with 10 reps each at a perceived exertion effort (RPE) of 5-7 on a scale of 1 to 10; (3) Aerobic exercise: starting at 15 mins, increasing by 5 mins biweekly to 30 mins by week 7; (4) Cool-down (general mobility); (5) Application of cohesive compressive bandage on the affected upper limb, worn for 2 hours post-session, removed at home. Participants may add a cotton bandage and finger bandage if needed.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hospital Clínico Universitario de Valladolid

OTHER

Sponsor Role: collaborator

European University Miguel de Cervantes

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alejandro Santos Lozano, PhD

Role: PRINCIPAL_INVESTIGATOR

Universidad Europea Miguel de Cervantes

Locations

European University Miguel of Cervantes

Valladolid, Castille and León, Spain

Countries

Spain

References

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.

Reference Type: BACKGROUND

PMID: 32521126 (View on PubMed)

Other Identifiers

PI-DOC005-BCRL

Identifier Type: -

Identifier Source: org_study_id