Physical Capacity in Hodgkin Lymphoma Survivors

NCT ID: NCT04636255

Last Updated: 2023-05-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-21

Study Completion Date

2023-10-21

Brief Summary

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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

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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.

Conditions

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Hodgkin Lymphoma, Adult Cardiovascular Diseases Radiation Effect Chemotherapy Effect

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Exercise training group

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

Group Type EXPERIMENTAL

Physical Characteristics

Intervention Type PROCEDURE

Body Weight, Height

Assessment of Heart rate variability

Intervention Type DIAGNOSTIC_TEST

Holter 24h

Blood Pressure and Cardiac Autonomic Control

Intervention Type DIAGNOSTIC_TEST

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

Evaluation of Baroreflex Control

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Echocardiogram

Assessment of Coronary Anatomy and Calcium Score

Intervention Type DIAGNOSTIC_TEST

Angiotomography

Blood Assessments

Intervention Type DIAGNOSTIC_TEST

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

Physical Capacity

Intervention Type DIAGNOSTIC_TEST

Cardiopulmonary Exercise Test.

Physical Training

Intervention Type 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.

Control Group

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

Group Type SHAM_COMPARATOR

Physical Characteristics

Intervention Type PROCEDURE

Body Weight, Height

Assessment of Heart rate variability

Intervention Type DIAGNOSTIC_TEST

Holter 24h

Blood Pressure and Cardiac Autonomic Control

Intervention Type DIAGNOSTIC_TEST

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

Evaluation of Baroreflex Control

Intervention Type 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

Intervention Type DIAGNOSTIC_TEST

Echocardiogram

Assessment of Coronary Anatomy and Calcium Score

Intervention Type DIAGNOSTIC_TEST

Angiotomography

Blood Assessments

Intervention Type DIAGNOSTIC_TEST

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

Physical Capacity

Intervention Type DIAGNOSTIC_TEST

Cardiopulmonary Exercise Test.

Interventions

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Physical Characteristics

Body Weight, Height

Intervention Type PROCEDURE

Assessment of Heart rate variability

Holter 24h

Intervention Type DIAGNOSTIC_TEST

Blood Pressure and Cardiac Autonomic Control

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

Intervention Type DIAGNOSTIC_TEST

Evaluation of Baroreflex Control

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

Cardiac Function and Structure

Echocardiogram

Intervention Type DIAGNOSTIC_TEST

Assessment of Coronary Anatomy and Calcium Score

Angiotomography

Intervention Type DIAGNOSTIC_TEST

Blood Assessments

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

Intervention Type DIAGNOSTIC_TEST

Physical Capacity

Cardiopulmonary Exercise Test.

Intervention Type DIAGNOSTIC_TEST

Physical Training

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Sao Paulo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Carlos E Negrao, PhD

Role: PRINCIPAL_INVESTIGATOR

Instituto do Coracao, HCFMUSP, Faculdade de Medicina, Universidade de Sao Paulo

Locations

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Luciana de Souza Santos

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Countries

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Brazil

Central Contacts

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Luciana S Santos

Role: CONTACT

551126615043

Marilia RH Santos, PhD

Role: CONTACT

551126615043

Facility Contacts

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Luciana de S Santos

Role: primary

551126615043

Marilia RH Santos, PhD

Role: backup

551126615043

References

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

Reference Type BACKGROUND
PMID: 26541251 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17194904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30955352 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24613809 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22570290 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12163425 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17119114 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25257632 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25677317 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25911667 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25424360 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25257631 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12104056 (View on PubMed)

Other Identifiers

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432715154

Identifier Type: -

Identifier Source: org_study_id

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