Physical Capacity in Hodgkin Lymphoma Survivors

Cardiovascular Diseases Clinical Trial

Official title:

Physical Capacity Evaluation and Effects of ExerciseTraining on Hodgkin Lymphoma Survivors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04636255
• Other study ID #: 432715154
• Status: Recruiting
• Phase: N/A
• Start date: October 21, 2017
• Est. completion date: October 21, 2023

Study information

• Verified date: May 2022
• Source: University of Sao Paulo General Hospital
• Contact: Luciana S Santos
• Phone: 551126615043
• Email: gglusantos[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: October 21, 2023
• Est. primary completion date: October 21, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Chemotherapy Effect
• Hodgkin Disease
• Hodgkin Lymphoma, Adult
• Lymphoma
• Radiation Effect

Intervention

Procedure:
• Physical Characteristics
Body Weight, Height

Diagnostic Test:
• Assessment of Heart rate variability
Holter 24h
• Blood Pressure and Cardiac Autonomic Control
Non-invasive photoplethysmography (Finometer® PRO) monitored by the electrocardiogram and respiratory frequency by a piezoelectric chest strap.
• 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.
• Cardiac Function and Structure
Echocardiogram
• Assessment of Coronary Anatomy and Calcium Score
Angiotomography
• Blood Assessments
Serum and Plasma will be extracted by centrifugation. NT-pro BNP (Roche™) and c-TnI (imunoassay Elecys 2010).
• Physical Capacity
Cardiopulmonary Exercise Test.

Procedure:
• 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.

Locations

Country	Name	City	State
Brazil	Luciana de Souza Santos	Sao Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (13)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: J Clin Oncol. 2007 Apr 20;25(12):1635. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

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