Physical Capacity in Hodgkin Lymphoma Survivors

NCT04636255 | Completed

• 1 other identifier: 432715154
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hodgkin Lymphoma, Adult; Cardiovascular Diseases; Radiation Effect; Chemotherapy Effect

Keywords

Oxygen Consumption; Physical Training; Heart Hate; Cardioprotection

Outcome Measures

Primary Outcomes (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).

  4 months

Secondary Outcomes (2)

• Heart Hate (beat/min)

  4 months

• Cardiac Function - Ejection Fraction

  4 months

Study Arms (2)

Exercise training group

EXPERIMENTAL

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

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 Group

SHAM COMPARATOR

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

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

Interventions

Physical Characteristics PROCEDURE

Body Weight, Height

Control Group; Exercise training group

Assessment of Heart rate variability DIAGNOSTIC_TEST

Holter 24h

Control Group; Exercise training group

Blood Pressure and Cardiac Autonomic Control DIAGNOSTIC_TEST

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

Control Group; Exercise training group

Evaluation of Baroreflex Control DIAGNOSTIC_TEST

The magnitude and latency of the baroreflex control of the heart rate will be assessed by bivariate analysis using the autoregressive method.

Control Group; Exercise training group

Cardiac Function and Structure DIAGNOSTIC_TEST

Echocardiogram

Control Group; Exercise training group

Assessment of Coronary Anatomy and Calcium Score DIAGNOSTIC_TEST

Angiotomography

Control Group; Exercise training group

Blood Assessments DIAGNOSTIC_TEST

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

Control Group; Exercise training group

Physical Capacity DIAGNOSTIC_TEST

Cardiopulmonary Exercise Test.

Control Group; Exercise training group

Physical Training 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.

Exercise training group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Luciana de Souza Santos

São Paulo, São Paulo, 05403-900, Brazil

Location

Related Publications (13)

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

  PMID: 26541251 BACKGROUND

• 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.

  PMID: 17194904 BACKGROUND

• 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.

  PMID: 30955352 BACKGROUND

• 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.

  PMID: 24613809 BACKGROUND

• 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.

  PMID: 22570290 BACKGROUND

• 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.

  PMID: 12163425 BACKGROUND

• 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.

  PMID: 17119114 BACKGROUND

• 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.

  PMID: 25257632 BACKGROUND

• 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.

  PMID: 25677317 BACKGROUND

• 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.

  PMID: 25911667 BACKGROUND

• 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.

  PMID: 25424360 BACKGROUND

• 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.

  PMID: 25257631 BACKGROUND

• 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.

  PMID: 12104056 BACKGROUND

MeSH Terms

Conditions

Hodgkin Disease; Cardiovascular Diseases

Interventions

Blood Pressure; Physical Conditioning, Human

Condition Hierarchy (Ancestors)

Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Vital Signs; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Carlos E Negrao, PhD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2020
• First Posted: November 19, 2020
• Study Start: October 21, 2017
• Primary Completion: October 21, 2022
• Study Completion: October 21, 2023
• Last Updated: May 4, 2026

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)