Physical Capacity in Hodgkin Lymphoma Survivors

Not Applicable

• Conditions: Radiation Effect; Chemotherapy Effect; Cardiovascular Diseases; Hodgkin Lymphoma, Adult
• Interventions: Procedure: Physical Characteristics; Diagnostic Test: Assessment of Heart rate variability; Diagnostic Test: Blood Pressure and Cardiac Autonomic Control; Diagnostic Test: Evaluation of Baroreflex Control; Diagnostic Test: Cardiac Function and Structure; Diagnostic Test: Assessment of Coronary Anatomy and Calcium Score; Diagnostic Test: Blood Assessments; Diagnostic Test: Physical Capacity; Procedure: Physical Training

• Registration Number: NCT04636255
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

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.

Detailed 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.

Study Timeline

• Study Start: 2017-10-21
• Study First Submitted: 2020-11-12
• Study First Submitted QC: 2020-11-12
• Study First Posted: 2020-11-19
• Status Verified: 2022-05
• Primary Completion: 2022-10-21
• Last Update Submitted: 2023-05-09
• Last Update Posted: 2023-05-10
• Study Completion: 2023-10-21

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Control Group	Physical Capacity	Patients will be only clinically followed up. They will not perform exercise training.
Exercise training group	Physical Characteristics	Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Exercise training group	Blood Pressure and Cardiac Autonomic Control	Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Control Group	Physical Characteristics	Patients will be only clinically followed up. They will not perform exercise training.
Control Group	Cardiac Function and Structure	Patients will be only clinically followed up. They will not perform exercise training.
Exercise training group	Evaluation of Baroreflex Control	Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Exercise training group	Cardiac Function and Structure	Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Control Group	Blood Pressure and Cardiac Autonomic Control	Patients will be only clinically followed up. They will not perform exercise training.
Control Group	Assessment of Coronary Anatomy and Calcium Score	Patients will be only clinically followed up. They will not perform exercise training.
Control Group	Evaluation of Baroreflex Control	Patients will be only clinically followed up. They will not perform exercise training.
Exercise training group	Assessment of Heart rate variability	Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Exercise training group	Assessment of Coronary Anatomy and Calcium Score	Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Exercise training group	Blood Assessments	Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Exercise training group	Physical Capacity	Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Exercise training group	Physical Training	Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Control Group	Assessment of Heart rate variability	Patients will be only clinically followed up. They will not perform exercise training.
Control Group	Blood Assessments	Patients will be only clinically followed up. They will not perform exercise training.

Primary Outcome Measures

Name	Time	Method
Physical Capacity - Peak oxygen consumption (mL/kg/min)	4 months	Oxygen consuption in crescent effort will be calculated by aggregation of volume (mL), body weight (Kg) and time (minutes).

Secondary Outcome Measures

Name	Time	Method
Heart Hate (beat/min)	4 months	Post-exercise heart rate will be evaluated by the number of beats in time masurement (one minute).
Cardiac Function - Ejection Fraction	4 months	Ejection Fraction (EF=ESV-EDV/EDV) combines end systolic (ESV) and diastolic volumes (EDV)(mL)

Trial Locations

Locations (1)

Luciana de Souza Santos; 🇧🇷 Sao Paulo, SP, Brazil