Clinical trial NCT04636255: Physical Capacity in Hodgkin Lymphoma Survivors
Official title: Physical Capacity Evaluation and Effects of ExerciseTraining on Hodgkin Lymphoma Survivors
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Hodgkin Lymphoma, Adult
Cardiovascular Diseases
Radiation Effect
Chemotherapy Effect
Keywords: Oxygen Consumption
Physical Training
Heart Hate
Cardioprotection
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
First posted: 2020-11-19
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Physical Capacity - Peak oxygen consumption (mL/kg/min)
timeFrame: 4 months
Secondary outcomes:
measure: Heart Hate (beat/min)
timeFrame: 4 months
measure: Cardiac Function - Ejection Fraction
timeFrame: 4 months
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Luciana de Souza Santos
state: SP
Study officials:
affiliation: Instituto do Coracao, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
name: Carlos E Negrao, PhD
role: PRINCIPAL_INVESTIGATOR
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