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Hodgkin Lymphoma, AdultNCT04636255

Physical Capacity in Hodgkin Lymphoma Survivors

A study testing Physical Characteristics, Assessment of Heart rate variability and Cardiac Function and Structure in people with Hodgkin Lymphoma, Adult and Cardiovascular Diseases, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Physical Characteristics, Assessment of Heart rate variability and Cardiac Function and Structure
Type of treatment
Surgery or procedure
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteBrazil
Study dates
21 Oct 2017to 21 Oct 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Luciana de Souza Santos

    São Paulo, São Paulo, 05403-900

Other trials in Brazil

About this study

Official title: Physical Capacity Evaluation and Effects of ExerciseTraining on 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.

Read the 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.

Being tested
Physical Characteristics, Assessment of Heart rate variability, Blood Pressure and Cardiac Autonomic Control, Evaluation of Baroreflex Control, Cardiac Function and Structure
Keywords
Oxygen Consumption, Physical Training, Heart Hate, Cardioprotection
Medical subject headings
Hodgkin Disease, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Physical CharacteristicsProcedure or surgery

    Body Weight, Height

  • Assessment of Heart rate variabilityDiagnostic test

    Holter 24h

  • Blood Pressure and Cardiac Autonomic ControlDiagnostic test

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

  • Evaluation of Baroreflex ControlDiagnostic 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 StructureDiagnostic test

    Echocardiogram

  • Assessment of Coronary Anatomy and Calcium ScoreDiagnostic test

    Angiotomography

  • Blood AssessmentsDiagnostic test

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

  • Physical CapacityDiagnostic test

    Cardiopulmonary Exercise Test.

  • Physical TrainingProcedure or surgery

    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.

Study groups in NCT04636255
Study groupRoleWhat they receive
Exercise training groupExperimentalPatients in the experimental group, under clinic follow up will perform combined exercise training for 16 weeks
Receives: 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
Control GroupSham comparatorPatients will be only clinically followed up. They will not perform exercise training.
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 4 months

Secondary outcomes (2)

  1. Heart Hate (beat/min)

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

    Measured: 4 months

  2. Cardiac Function - Ejection Fraction

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

    Measured: 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Nov 2020
  2. Study start21 Oct 2017
  3. Primary completion21 Oct 2022
  4. Study completion21 Oct 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Factorial
Masking
None (open label)
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04636255
Sponsor's protocol ID
432715154
Status last verified
May 2022
First submitted
12 Nov 2020
Last updated
4 May 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ansell SM. Hodgkin Lymphoma: Diagnosis and Treatment. Mayo Clin Proc. 2015 Nov;90(11):1574-83. doi: 10.1016/j.mayocp.2015.07.005.

    PubMed 26541251

  • Heidenreich PA, Schnittger I, Strauss HW, Vagelos RH, Lee BK, Mariscal CS, Tate DJ, Horning SJ, Hoppe RT, Hancock SL. Screening for coronary artery disease after mediastinal irradiation for Hodgkin's disease. J Clin Oncol. 2007 Jan 1;25(1):43-9. doi: 10.1200/JCO.2006.07.0805.

    PubMed 17194904

  • Gilchrist SC, Barac A, Ades PA, Alfano CM, Franklin BA, Jones LW, La Gerche A, Ligibel JA, Lopez G, Madan K, Oeffinger KC, Salamone J, Scott JM, Squires RW, Thomas RJ, Treat-Jacobson DJ, Wright JS; American Heart Association Exercise, Cardiac Rehabilitation, and Secondary Prevention Committee of the Council on Clinical Cardiology; Council on Cardiovascular and Stroke Nursing; and Council on Peripheral Vascular Disease. Cardio-Oncology Rehabilitation to Manage Cardiovascular Outcomes in Cancer Patients and Survivors: A Scientific Statement From the American Heart Association. Circulation. 2019 May 21;139(21):e997-e1012. doi: 10.1161/CIR.0000000000000679.

    PubMed 30955352

  • Girinsky T, M'Kacher R, Lessard N, Koscielny S, Elfassy E, Raoux F, Carde P, Santos MD, Margainaud JP, Sabatier L, Ghalibafian M, Paul JF. Prospective coronary heart disease screening in asymptomatic Hodgkin lymphoma patients using coronary computed tomography angiography: results and risk factor analysis. Int J Radiat Oncol Biol Phys. 2014 May 1;89(1):59-66. doi: 10.1016/j.ijrobp.2014.01.021. Epub 2014 Mar 7.

    PubMed 24613809

  • Hoppe RT, Advani RH, Ai WZ, Ambinder RF, Aoun P, Bello CM, Bierman PJ, Blum KA, Chen R, Dabaja B, Duron Y, Forero A, Gordon LI, Hernandez-Ilizaliturri FJ, Hochberg EP, Maloney DG, Mansur D, Mauch PM, Metzger M, Moore JO, Morgan D, Moskowitz CH, Poppe M, Pro B, Winter JN, Yahalom J, Sundar H; National Comprehensive Cancer Network. Hodgkin lymphoma, version 2.2012 featured updates to the NCCN guidelines. J Natl Compr Canc Netw. 2012 May;10(5):589-97. doi: 10.6004/jnccn.2012.0061.

    PubMed 22570290

  • Kavanagh T, Mertens DJ, Hamm LF, Beyene J, Kennedy J, Corey P, Shephard RJ. Prediction of long-term prognosis in 12 169 men referred for cardiac rehabilitation. Circulation. 2002 Aug 6;106(6):666-71. doi: 10.1161/01.cir.0000024413.15949.ed.

    PubMed 12163425

  • Aleman BM, van den Belt-Dusebout AW, De Bruin ML, van 't Veer MB, Baaijens MH, de Boer JP, Hart AA, Klokman WJ, Kuenen MA, Ouwens GM, Bartelink H, van Leeuwen FE. Late cardiotoxicity after treatment for Hodgkin lymphoma. Blood. 2007 Mar 1;109(5):1878-86. doi: 10.1182/blood-2006-07-034405. Epub 2006 Nov 21.

    PubMed 17119114

  • Koelwyn GJ, Jones LW, Moslehi J. Unravelling the causes of reduced peak oxygen consumption in patients with cancer: complex, timely, and necessary. J Am Coll Cardiol. 2014 Sep 30;64(13):1320-2. doi: 10.1016/j.jacc.2014.07.949. No abstract available.

    PubMed 25257632

  • Groarke JD, Tanguturi VK, Hainer J, Klein J, Moslehi JJ, Ng A, Forman DE, Di Carli MF, Nohria A. Abnormal exercise response in long-term survivors of hodgkin lymphoma treated with thoracic irradiation: evidence of cardiac autonomic dysfunction and impact on outcomes. J Am Coll Cardiol. 2015 Feb 17;65(6):573-83. doi: 10.1016/j.jacc.2014.11.035.

    PubMed 25677317

  • Wilson MG, Ellison GM, Cable NT. Basic science behind the cardiovascular benefits of exercise. Heart. 2015 May 15;101(10):758-65. doi: 10.1136/heartjnl-2014-306596.

    PubMed 25911667

  • da Silva VP, de Oliveira NA, Silveira H, Mello RG, Deslandes AC. Heart rate variability indexes as a marker of chronic adaptation in athletes: a systematic review. Ann Noninvasive Electrocardiol. 2015 Mar;20(2):108-18. doi: 10.1111/anec.12237. Epub 2014 Nov 26.

    PubMed 25424360

  • Cramer L, Hildebrandt B, Kung T, Wichmann K, Springer J, Doehner W, Sandek A, Valentova M, Stojakovic T, Scharnagl H, Riess H, Anker SD, von Haehling S. Cardiovascular function and predictors of exercise capacity in patients with colorectal cancer. J Am Coll Cardiol. 2014 Sep 30;64(13):1310-9. doi: 10.1016/j.jacc.2014.07.948.

    PubMed 25257631

  • Pumprla J, Howorka K, Groves D, Chester M, Nolan J. Functional assessment of heart rate variability: physiological basis and practical applications. Int J Cardiol. 2002 Jul;84(1):1-14. doi: 10.1016/s0167-5273(02)00057-8.

    PubMed 12104056

Questions about this trial

What is this clinical trial studying?

A study testing Physical Characteristics, Assessment of Heart rate variability and Cardiac Function and Structure in people with Hodgkin Lymphoma, Adult and Cardiovascular Diseases, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Physical Capacity - Peak oxygen consumption (mL/kg/min) (time frame: 4 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04636255, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 May 2026.

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