Early Detection of Broken Hearts in Cancer Patients

NCT ID: NCT02086695

Last Updated: 2016-01-29

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 43 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2015-09-30

Brief Summary

The early detection of BVZ or Sunitinib mediated cardiotoxicity using cardiac biomarkers and novel Transthoracic Echocardiogram (TTE) techniques may allow one to adjust treatment and/or administer prophylactic cardioprotective agents, prior to the development of irreversible cardiac dysfunction. We hypothesize that cardiac biomarkers, TVI/strain-derived indices will be able to accurately detect subtle cardiac injury at a time when conventional Left Ventricular Ejection Fraction (LVEF) remains normal in BVZ or Sunitinib mediated cardiotoxicity. Additionally, we hypothesize that Endothelial Function Test (EndoPAT) testing can detect early BVZ or Sunitinib mediated endothelial dysfunction.

Detailed Description

A total of 100 individuals (50 receiving BVZ and 50 receiving Sunitinib) will be prospectively enrolled . (80 at Mayo Clinic [80 receiving BVZ, Sunitinib ,or Pazopanib] and 20 at St. Boniface General Hospital (SBGH)). Patients receiving either BVZ 5mg/kg iv ,Sunitinib 50 mg po daily, or Pazopanib for advanced Metastatic carcinoma will be screened for potential eligibility in the study. For metastatic renal cancer treatments, Sunitinib doses are (oral) 50 mg once a day for 4 weeks followed by a two week off period. The six week cycle is then repeated. In case of toxicities observed with the dose, a 25% reduction in the daily dose during the "on" period is performed (37.5 mg). Patients will be studied at 7 time points: i) Baseline; ii) Day 1; iii) Day 5; iv) 4-6 weeks ; v) 3 months; vi) 6 months after the initiation of both drugs (BVZ and Sunitinib) ; and vii) 12 months after the initiation of BVZ drug only (Figure 1). Three visits (baseline, 4-6 weeks , and 3 months) are considered part of standard clinical care, and four visits are for research. At each visit, in addition to standard of care provided by the Oncologist, blood will be drawn to measure high sensitivity troponin-T (hsTnT) and Natriuretic-proBNP. The patients will also undergo a TTE with tissue velocity imaging (TVI), strain and left ventricular opacification (LVO) and myocardial perfusion at each time point. EndoPAT test will also be performed at baseline, and 3 months. The baseline, 4-6 weeks, and 3 month visits will be part of your standard clinical care and followup.

Conditions

Cardiotoxicity

Keywords

Chemotherapy; Cardiotoxicity

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cancer Group

All subjects with cancer who will be treated with anyone of the following chemotherapy drugs; Pazopanib, Sutent or Bevacizumab

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

1. Patients with advanced cancer

2. Treatment plan includes BVZ ,Sunitinib, or Pazopanib

3. Ages 18 - 90 years old -

Exclusion Criteria

-

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Asper Foundation

UNKNOWN

Sponsor Role: collaborator

St. Boniface Hospital

OTHER

Sponsor Role: collaborator

Lantheus Medical Imaging

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Sharon Mulvagh

Consultant of Cardiology Noninvasive

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Mayo Clinic

Rochester, Minnesota, United States

St. Boniface General Hospital

Winnipeg, Manitoba, Canada

Countries

United States; Canada

Other Identifiers

12-005362

Identifier Type: -

Identifier Source: org_study_id