Physical Capacity in Hodgkin Lymphoma Survivors

University of Sao Paulo General Hospital

Status: Unknown

Conditions: Hodgkin Lymphoma, Adult; Chemotherapy Effect; Cardiovascular Diseases; Radiation Effect

Treatments: Diagnostic Test: Assessment of Heart rate variability; Diagnostic Test: Physical Capacity; Procedure: Physical Characteristics; Diagnostic Test: Evaluation of Baroreflex Control; Diagnostic Test: Assessment of Coronary Anatomy and Calcium Score; Procedure: Physical Training; Diagnostic Test: Cardiac Function and Structure; Diagnostic Test: Blood Pressure and Cardiac Autonomic Control; Diagnostic Test: Blood Assessments

Study type: Interventional

Funder types: Other

Identifiers

NCT04636255

432715154

Details and patient eligibility

About

The study aims to investigate if physical capacity obtained in the cardiopulmonary exercise test can predict cardiovascular alterations in Hodgkin Lymphoma (HL) Survivors. In addition, to study the effects of exercise training on physical capacity and cardiovascular responses in these patients.

Full description

Hodgkin Lymphoma (HL) is a hematological neoplasia that mainly affects young people. Anthracycline-based chemotherapy, followed or not by mediastinal radiotherapy, substantially improves prognosis in this set of patients. Observational studies have shown that cardiovascular disease is the most non oncologic cause of death in this population. Coronary artery disease (CAD) affects 26% of survivors after 10 years of absence of HL . However, the early intervention and the assessment to predict the cardiovascular risk remain little known. In this study, the investigators will test the hypothesis that physical capacity can predict the cardiovascular alterations in HL Survivors. In addition, exercise training improves physical capacity and heart rate responses in this set of patients.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Hodgkin Lymphoma Survivors
• Over 18 years old
• Chemotherapy with anthracycline and mediastinal radiotherapy in the last 5 years or more

Exclusion criteria

• Renal insufficiency
• Pregnant women,
• Iodinated contrast allergy,
• Life expectancy less than 1 year.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Exercise training group

Experimental group

Description:

Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks

Treatment:

Diagnostic Test: Assessment of Coronary Anatomy and Calcium Score

Procedure: Physical Training

Diagnostic Test: Blood Assessments

Diagnostic Test: Evaluation of Baroreflex Control

Diagnostic Test: Cardiac Function and Structure

Diagnostic Test: Assessment of Heart rate variability

Diagnostic Test: Physical Capacity

Diagnostic Test: Blood Pressure and Cardiac Autonomic Control

Procedure: Physical Characteristics

Control Group

Sham Comparator group

Description:

Patients will be only clinically followed up. They will not perform exercise training.

Treatment:

Diagnostic Test: Assessment of Coronary Anatomy and Calcium Score

Diagnostic Test: Blood Assessments

Diagnostic Test: Evaluation of Baroreflex Control

Diagnostic Test: Cardiac Function and Structure

Diagnostic Test: Assessment of Heart rate variability

Diagnostic Test: Physical Capacity

Diagnostic Test: Blood Pressure and Cardiac Autonomic Control

Procedure: Physical Characteristics