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Physical Capacity in Hodgkin Lymphoma Survivors

Primary Purpose

Hodgkin Lymphoma, Adult, Cardiovascular Diseases, Radiation Effect

Status
Recruiting
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Physical Characteristics
Assessment of Heart rate variability
Blood Pressure and Cardiac Autonomic Control
Evaluation of Baroreflex Control
Cardiac Function and Structure
Assessment of Coronary Anatomy and Calcium Score
Blood Assessments
Physical Capacity
Physical Training
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hodgkin Lymphoma, Adult focused on measuring Oxygen Consumption, Physical Training, Heart Hate, Cardioprotection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Luciana de Souza SantosRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Exercise training group

Control Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
November 12, 2020
Last Updated
May 9, 2023
Sponsor
University of Sao Paulo General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04636255
Brief Title
Physical Capacity in Hodgkin Lymphoma Survivors
Official Title
Physical Capacity Evaluation and Effects of ExerciseTraining on Hodgkin Lymphoma Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 21, 2017 (Actual)
Primary Completion Date
October 21, 2022 (Actual)
Study Completion Date
October 21, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hodgkin Lymphoma, Adult, Cardiovascular Diseases, Radiation Effect, Chemotherapy Effect
Keywords
Oxygen Consumption, Physical Training, Heart Hate, Cardioprotection

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Exercise training group
Arm Type
Experimental
Arm Description
Patients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
Patients will be only clinically followed up. They will not perform exercise training.
Intervention Type
Procedure
Intervention Name(s)
Physical Characteristics
Intervention Description
Body Weight, Height
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of Heart rate variability
Intervention Description
Holter 24h
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood Pressure and Cardiac Autonomic Control
Intervention Description
Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap.
Intervention Type
Diagnostic Test
Intervention Name(s)
Evaluation of Baroreflex Control
Intervention Description
The magnitude and latency of the baroreflex control of the heart rate will be assessed by bivariate analysis using the autoregressive method.
Intervention Type
Diagnostic Test
Intervention Name(s)
Cardiac Function and Structure
Intervention Description
Echocardiogram
Intervention Type
Diagnostic Test
Intervention Name(s)
Assessment of Coronary Anatomy and Calcium Score
Intervention Description
Angiotomography
Intervention Type
Diagnostic Test
Intervention Name(s)
Blood Assessments
Intervention Description
Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010).
Intervention Type
Diagnostic Test
Intervention Name(s)
Physical Capacity
Intervention Description
Cardiopulmonary Exercise Test.
Intervention Type
Procedure
Intervention Name(s)
Physical Training
Intervention Description
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 Outcome Measure Information:
Title
Physical Capacity - Peak oxygen consumption (mL/kg/min)
Description
Oxygen consuption in crescent effort will be calculated by aggregation of volume (mL), body weight (Kg) and time (minutes).
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Heart Hate (beat/min)
Description
Post-exercise heart rate will be evaluated by the number of beats in time masurement (one minute).
Time Frame
4 months
Title
Cardiac Function - Ejection Fraction
Description
Ejection Fraction (EF=ESV-EDV/EDV) combines end systolic (ESV) and diastolic volumes (EDV)(mL)
Time Frame
4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luciana S Santos
Phone
551126615043
Email
gglusantos@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marilia RH Santos, PhD
Phone
551126615043
Email
marilia.higuchi@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carlos E Negrao, PhD
Organizational Affiliation
Instituto do Coracao, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo
Official's Role
Principal Investigator
Facility Information:
Facility Name
Luciana de Souza Santos
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luciana de S Santos
Phone
551126615043
Email
gglusantos@gmail.com
First Name & Middle Initial & Last Name & Degree
Marilia RH Santos, PhD
Phone
551126615043
Email
marilia.higuchi@gmail.com
First Name & Middle Initial & Last Name & Degree
Carlos E Negrao, PhD

12. IPD Sharing Statement

Plan to Share IPD
No
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Citation
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Physical Capacity in Hodgkin Lymphoma Survivors

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