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NCT Number: NCT04636255

Physical Capacity in Hodgkin Lymphoma Survivors

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.

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Key information

Conditions

Hodgkin Lymphoma, Adult Cardiovascular Diseases Chemotherapy Effect Hemic and Lymphatic Diseases Hodgkin Disease Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Radiation Effect

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Luciana de Souza Santos

São Paulo, 05403-900, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Physical Characteristics

Procedure

Body Weight, Height

Assessment of Heart rate variability

Diagnostic Test

Holter 24h

Blood Pressure and Cardiac Autonomic Control

Diagnostic Test

Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap.

Evaluation of Baroreflex Control

Diagnostic Test

The magnitude and latency of the baroreflex control of the heart rate will be assessed by bivariate analysis using the autoregressive method.

Cardiac Function and Structure

Diagnostic Test

Echocardiogram

Assessment of Coronary Anatomy and Calcium Score

Diagnostic Test

Angiotomography

Blood Assessments

Diagnostic Test

Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010).

Physical Capacity

Diagnostic Test

Cardiopulmonary Exercise Test.

Physical training

Procedure

Aerobic exercise: 48 sessions of 60 minutes: 5 minutes of warm-up, 40 minutes of exercise. Resistance exercise: 10 minutes of exercise and 5 minutes of recovery.

Primary outcomes

  1. Physical Capacity - Peak oxygen consumption (mL/kg/min)

    Time frame: 4 months

    Oxygen consuption in crescent effort will be calculated by aggregation of volume (mL), body weight (Kg) and time (minutes).

Secondary outcomes

  1. Heart Hate (beat/min)

    Time frame: 4 months

    Post-exercise heart rate will be evaluated by the number of beats in time masurement (one minute).

  2. Cardiac Function - Ejection Fraction

    Time frame: 4 months

    Ejection Fraction (EF=ESV-EDV/EDV) combines end systolic (ESV) and diastolic volumes (EDV)(mL)

Sponsors and collaborators

Lead sponsor

University of Sao Paulo General Hospital

Other

Registry information

Official study title

Physical Capacity Evaluation and Effects of ExerciseTraining on Hodgkin Lymphoma Survivors

Important dates

Study start
2017
Primary completion
2022
Study completion
2023
First posted
Nov 19, 2020
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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