Impact of Platinum-based Cancer Treatment on Endothelial Function

NCT04681560 | Completed DMC

• 1 other identifier: 1019
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

High Blood Pressure; Cardiovascular Complication

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• Evaluation of blood pressure

  In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)

• Evaluation of flow-mediated vasodilation and pulse-wave velocity

  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

  In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (2)

Olga Andreeva

Moscow, 119421, Russia

Location

First Moscow State Medical University.

Moscow, Russia

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Dmitry Shchekochikhin, PhD

  I.M. Sechenov First Moscow State Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2020
• First Posted: December 23, 2020
• Study Start: January 18, 2018
• Primary Completion: December 9, 2019
• Study Completion: January 20, 2020
• Last Updated: December 23, 2020

Record last verified: 2019-09

Locations

RU (2)