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Impact of Cancer Therapy on Myocardial Function in Patients With Esophagus Cancer (Heartcheck)

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ClinicalTrials.gov Identifier: NCT03619317
Recruitment Status : Recruiting
First Posted : August 7, 2018
Last Update Posted : August 7, 2018
Sponsor:
Collaborator:
Danish Cancer Society
Information provided by (Responsible Party):
Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby

Brief Summary:

Introduction: Patients with cancer in esophagus and gastroesophageal junction (EGEJ) treated with chemoradiotherapy (chemoRT) have increased risk of cardiovascular disease. EGEJ patients often have frailty and pre-existing cardiovascular disease. This may disqualify them for standard trimodal curative treatment and offer surgery alone, chemoRT alone or palliative treatment only. The current understanding of radiation induced heart disease (RIHD) in EGEJ patients is limited. Hence, there is a need for additional studies. Especially on myocardial function during and after chemoRT as congestive heart failure is a serious complication associated with increased morbidity and mortality. Proton-based radiation therapy (RT) is a new alternative to standard photon-based radiation therapy, that is likely to reduce the risk of cardiovascular complications.

Hypothesis: Treatment with chemoRT might induce myocardial dysfunction, symptoms of heart failure and decreased physical performance in patients with EGEJ Cancer.

The aim: Is to investigate the influence on chemoRT on myocardial function in EGEJ patients and evaluate the cardiac prognosis and eventually identify potential high-risk patients who might benefit from proton-based RT instead of the current photon-based RT.

Method: From power calculation the investigators plan to include 56 patients with EGEJ cancer during a period of two years. Inclusions criteria: biopsy verified EGEJ cancer supported by findings from gastroscopy, PET CT scan and with the final diagnosis locally advanced, non-metastatic. The patients will be examined with serial cardiac investigations to evaluate if they develop impairment of the heart function during or after chemoRT. The investigations include; electrocardiogram, cardiac biomarkers, echocardiography and cardio pulmonary exercise test. The examinations will be performed at study entry (baseline) and after six weeks and again after six months.


Condition or disease
Cancer of Esophagus

  Show Detailed Description

Study Type : Observational
Estimated Enrollment : 56 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Chemo and Radiation Induced Systolic and Diastolic Myocardial Dysfunction in Patients With Cancer in Oesophagus and Gastroesophagael Junction - a Prospective Study
Actual Study Start Date : June 25, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


Group/Cohort
Cancer esophagus and gastroesophageal junction
EGEJ cancer patients referred to combined therapy of chemoRT and surgery can be included.



Primary Outcome Measures :
  1. • Left ventricular systolic function estimated by 2D longitudinal strain (GLS) and ejection fraction (EF) at rest and peak exercise [ Time Frame: From Baseline till 6 weeks after. ]
    where a decrease of peak GLS of 10 % is considered clinical significant.


Secondary Outcome Measures :
  1. • Change of NT-pro-BNP [ Time Frame: From Baseline till 6 weeks after. ]
    with a double increase provided that serum level is above >300 pmol/L after ChemoRT provided e-GFR >30 ml/min.

  2. • Change in TNT [ Time Frame: From Baseline till 6 weeks after. ]
    2 x upper normal value = >28 ng/l provided that Estimated glomerular filtration rate >50 ml/min.

  3. • Change of peak VO2 [ Time Frame: From Baseline till 6 weeks after. ]
    of 10% ml/kg/min after chemoRT compared to baseline.

  4. • Change in diastolic function [ Time Frame: From Baseline till 6 weeks after. ]
    defined as an increase of at least one diastolic grade

  5. • Admission to hospital with clinical heart failure. [ Time Frame: Baseline, after 4 weeks and 6 months. ]
    To investigate if the have had heart related admission to hospital

  6. • Dead - not cancer related. [ Time Frame: From Baseline till 6 weeks after. ]
    Dead that is not related to the cancer diagnosis

  7. • Increased use of diuretics compared to baseline [ Time Frame: Baseline, after 4 weeks and 6 months. ]
    accumulated use of thiazide, loop or aldosterone antagonists

  8. • Change in use of ace-inhibitors, betablockers, digoxin and hydralazine compared to baseline. [ Time Frame: From Baseline till 6 weeks after. ]
    Increased use of the drugs mentioned

  9. Left ventricular systolic function estimated by 2D longitudinal strain (GLS) and ejection fraction (EF) at rest and peak exercise [ Time Frame: From Baseline till 6 weeks after. ]
    where a decrease of EF 5 % (absolute) is considered clinical significant.



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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
  • Age < 18 years
  • Patients not being able to give informed consent (decided by the investigator).
  • Patients not being able to understand Danish language.
  • Acute myocardial infarct within the last 6 months.
  • Present clinical severe heart valve disease and/or congestive heart failure with left ejection fraction < 25 %.
  • Patients with prior thoracic radiation and overlapping RT fields.
Criteria

Inclusion Criteria:

  • Biopsy verified EGEJ cancer verified by gastroscopy, biopsy and PET/CT scan.
  • The final diagnosis must be locally advanced, non-metastatic as determined at a multidisciplinary team conference.
  • Patients referred to curative treatment with preoperative or definitive chemo- and radiotherapy.

Exclusion Criteria:


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03619317


Contacts
Contact: Mette MA Søndergaard, Cand.Med 004530130565 metast@rm.dk

Locations
Denmark
University Hospital of Aarhus, Department of Cardiology Recruiting
Aarhus N, Denmark, 8200
Contact: Mette Søndergaard    30130565    metast@rm.dk   
Contact: Steen Poulsen       steen.hvitfeldt@rm.dk   
Sponsors and Collaborators
Aarhus University Hospital Skejby
Danish Cancer Society
Investigators
Principal Investigator: Steen H Poulsen, MD phd DMSci Aarhus University Hopital, Skejby, Department of Cardiology

Publications:

Responsible Party: Steen Hvitfeldt Poulsen, Associate Professor, MD, Ph.D., DMSci, Aarhus University Hospital Skejby
ClinicalTrials.gov Identifier: NCT03619317     History of Changes
Other Study ID Numbers: 1-16-02-189-18
First Posted: August 7, 2018    Key Record Dates
Last Update Posted: August 7, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Steen Hvitfeldt Poulsen, Aarhus University Hospital Skejby:
Heartdisease
Radiation
Chemoradiotherapy
cardiovascular disease

Additional relevant MeSH terms:
Esophageal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases