Impact of Platinum-based Cancer Treatment on Endothelial Function

The Effect of Polychemotherapy on Endothelial Function Ans Vessel Age in Cancer Patients.

In this research we investigate endothelial function in cancer patients who received platinum based chemotherapy.

Study Overview

• Status: Completed
• Conditions: High Blood Pressure; Cardiovascular Complication

Detailed Description

The goal of the study is to evaluate endothelial function in patients with platinum-based versus non-platinum-based chemotherapy.

Endothelial function was evaluated via Angioscan( the apparatus that evaluate the stiffness of vessels by pulse wave velocity) and serum levels of endothelial nitric oxide synthase (ENOS),endothelin1.

Patients with gastrointestinal, ovarian, bladder and brest cancer would be included.

Patients with malignancies were followed-up from 2 weeks to 3 month after start of chemotherapy, Medical records and hospital databases were searched for all the patients treated with different chemotherapy treatment for any kind of cancer.

• Study Type: Observational
• Enrollment (Actual): 60

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 119421
    • Olga Andreeva
  • Moscow, Russian Federation
    • First Moscow State Medical University.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

In this study included 60 patients, that have diagnosis solid cancer of any stage and localisation.All of them is expected to start platinum based or non platinum based chemotherapy.The study proseeds in Chemotherapy department at City Hospital No.1.

Description

Inclusion Criteria:

• Subject has solid cancer
• Subject is expected to start chemotherapy

Exclusion Criteria:

• Pregnancy and lactation
• Severe impaired kidney function
• Severe hepatic impairment
• Mental disease
• Acute myocardial infarction 28 days ago or earlier
• Acute Cerebrovascular Event 1 month ago or earlier
• Rhythm disturbance that complicate pulse wave velocity evaluation

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of blood pressure	Both systolic and diastiolic blood pressure were measured in the office in the seated position, noninvasively.	Before start of chemotherapy (1 hour after including in the trial)
Evaluation of flow-mediated vasodilation and pulse-wave velocity	Flow-mediated dilatation and pulse-wave velocity were measured via "Angioscan" apparatus in the seated position.The cuff inflation period of 5 min was initially decided to produce adequate hyperaemia to allow flow-mediated dilatation. The scanning period used in our trial was 1 minite before and 9 minutes after the cuff deflation.	Before start of chemotherapy (1 hour after including in the trial)
Evaluation of concetration of ENOS and Big Endothelin in blood sampling	Blood was collected from the cubital vein to 10.0 ml/ 6.0 ml red top tubes (without clot activator). The sample was then separated by centrifugation. The serum was frozen to -20C.	Before start of chemotherapy (1 hour after including in the trial)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of blood pressure	Both systolic and diastiolic blood pressure was measured in the office in the seated position, noninvasively.	In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
Evaluation of flow-mediated vasodilation and pulse-wave velocity	Flow-mediated dilatation and pulse-wave velocity were measured via "Angioscan" apparatus in the seated position.The cuff inflation period of 5 min was initially decided to produce adequate hyperaemia to allow flow-mediated dilatation. The scanning period used in our trial was 1 minite before and 9 minutes after the cuff deflation.	In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
Evaluation of concetration of ENOS and Big Endothelin of blood sampling	Blood was collected from the cubital vein to 10.0 ml/ 6.0 ml red top tubes (without clot activator). The sample was then separated by centrifugation. The serum was frozen to -20C.	In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)

Collaborators and Investigators

• Sponsor: I.M. Sechenov First Moscow State Medical University
• Investigators: Principal Investigator: Dmitry Shchekochikhin, PhD, I.M. Sechenov First Moscow State Medical University

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 18, 2018
• Primary Completion (ACTUAL): December 9, 2019
• Study Completion (ACTUAL): January 20, 2020

Study Registration Dates

• First Submitted: April 18, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (ACTUAL): December 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): December 23, 2020
• Last Update Submitted That Met QC Criteria: December 18, 2020
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 1019

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No