Cardio-Oncology Rehabilitation in Breast Cancer Patients Undergoing Chemotherapy

NCT07823660 | Recruiting

• 2 other identifiers: Dipe - 2025019197992026.9.0000.5327
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Breast cancer is the most prevalent malignancy among women in Brazil, and Porto Alegre (Rio Grande do Sul) has one of the highest incidence rates in women under 50, with 165.5 cases per 100,000 women aged 40-49. Advances in cancer biology, treatment, and supportive care have improved outcomes, leading to increased survivorship. Regular physical exercise has been shown to be an effective strategy in both the prevention and management of breast cancer, and during chemotherapy, physical activity may reduce fatigue, improve quality of life, and increase cardiorespiratory fitness. This randomized clinical trial will enroll women diagnosed with breast cancer indicated for neoadjuvant or adjuvant chemotherapy. The study aims to characterize the clinical profile of these patients with respect to cardiovascular and functional effects of chemotherapy, and to evaluate an integrated cardio-oncology rehabilitation approach. The investigators expect to identify the clinical profile of breast cancer patients undergoing chemotherapy and establish associations with the study variables, as well as to assess the effect of a standardized exercise program on the cardiovascular and musculoskeletal systems and quality of life. Based on these results, the study aims to propose a complementary rehabilitation program, to be offered within the public health system, alongside pharmacological treatment during and after completion of the chemotherapy cycle.

Conditions

Breast Cancer

Keywords

Breast cancer; Chemotherapy; Cardio-oncology rehabilitation

Outcome Measures

Primary Outcomes (10)

• Change in Left Ventricular Ejection Fraction (LVEF)

  Left ventricular systolic function assessed by transthoracic echocardiography with strain analysis

  Baseline and 6 months

• Incidence of Cardiotoxicity

  Development of cancer therapy-related cardiac dysfunction, including asymptomatic/subclinical cases, defined by relative decline in global longitudinal strain (GLS) on echocardiography.

  Baseline and 6 months

• Change in Electrocardiographic Abnormalities and Arrhythmias

  ECG findings assessed as part of the echocardiographic evaluation. The ECG will be assessed for the following parameters: heart rate, cardiac rhythm (to identify arrhythmias), PR interval, QRS complex duration and morphology, QT/QTc interval, and ST-segment/T-wave changes.

  Baseline and 6 months

• Change in Resting Blood Pressure

  Measured before cardiopulmonary exercise testing (CPET)

  Baseline and 6 months

• Change in Blood Pressure During Exercise

  Measured during cardiopulmonary exercise testing (CPET)

  Baseline and 6 months

• Change in Resting Heart Rate

  Measured before cardiopulmonary exercise testing (CPET)

  Baseline and 6 months

• Change in Heart Rate During Exercise

  Measured during cardiopulmonary exercise testing (CPET)

  Baseline and 6 months

• Change in Peak Oxygen Consumption (VO2 Peak)

  Measured during cardiopulmonary exercise testing (CPET)

  Baseline and 6 months

• Fatigue Pictogram (Mota, Pimenta, Fitch, 2009)

  This pictorial instrument assesses fatigue intensity and fatigue interference with usual activities, each rated on a scale from 1 to 5, where higher scores indicate worse outcomes (greater fatigue intensity and greater interference with activities, respectively).

  Baseline, 3 months, and 6 months

• Modified Borg CR-10 Scale (Category-Ratio 10)

  This scale ranges from 0 (no exertion/dyspnea at all) to 10 (maximal/very, very severe exertion or dyspnea), where higher scores indicate worse perceived exertion or breathlessness.

  Baseline, 3 months, and 6 months

Secondary Outcomes (12)

• Change in Troponin

  Baseline and 6 months

• Change in BNP/NT-proBNP

  Baseline and 6 months

• Change in High-Sensitivity C-Reactive Protein (hs-CRP)

  Baseline and 6 months

• Change in TNF-alpha

  Baseline and 6 months

• European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Breast Cancer Module (EORTC QLQ-BR23)

  Baseline and 6 months

Study Arms (2)

Exercise Training Group

EXPERIMENTAL

Participants will undergo a cardio-oncology rehabilitation program with supervised exercise training sessions twice weekly at HCPA's Physical Rehabilitation Service (SFR). Assessments will be performed at baseline and at 3 and 6 months.

Behavioral: Cardio-Oncology Exercise Rehabilitation Program

Control Group

NO INTERVENTION

Participants will receive general health and nutritional guidance at the baseline assessment and will maintain usual care, without a structured exercise program. Assessments will be performed at baseline and at 3 and 6 months, following the same schedule as the intervention group.

Interventions

Cardio-Oncology Exercise Rehabilitation Program BEHAVIORAL

Structured, individualized exercise training sessions held twice weekly at HCPA's Physical Rehabilitation Service (SFR), aimed at mitigating chemotherapy-related cardiovascular and functional impairment in breast cancer patients.

Exercise Training Group

Eligibility Criteria

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

You may qualify if:

• Diagnosis of breast cancer
• Indicated for chemotherapy treatment
• Cardiovascularly stable
• Cleared for physical exercise
• Willing to participate in the study
• Physically able to perform the assessments and training sessions

You may not qualify if:

• Any decompensated disease that would compromise the ability to perform the training sessions
• Prior diagnosis of ischemic heart disease
• Prior diagnosis of valvular heart disease
• Prior diagnosis of cardiac arrhythmias
• Myocarditis within the past 6 months
• History of heart failure
• LVEF \<55% prior to initiation of chemotherapy
• Musculoskeletal disorders that limit the ability to perform the exercises
• Diagnosis of peripheral arterial occlusive disease within the past 6 months
• Ankle-brachial index \<0.4
• Cognitive impairment that would compromise understanding of study procedures or participation

Sponsors & Collaborators

• Hospital de Clinicas de Porto Alegre: lead

Study Sites (1)

Hospital de Clinicas de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90410000, Brazil

RECRUITING

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MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Rosane M Nery, PhD

  Hospital de Clinicas de Porto Alegre

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosane M Nery, PhD

CONTACT

+55 51 33597634; rnery@hcpa.edu.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2026
• First Posted: September 16, 2026
• Study Start: December 1, 2025
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 16, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)