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Completed

NCT Number: NCT04681560

Impact of Platinum-based Cancer Treatment on Endothelial Function

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

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Key information

Conditions

High Blood Pressure Cardiovascular Complication Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Moscow State Medical University., Moscow, Russia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Evaluation of blood pressure

    Time frame: Before start of chemotherapy (1 hour after including in the trial)

    Both systolic and diastiolic blood pressure were measured in the office in the seated position, noninvasively.

  2. Evaluation of flow-mediated vasodilation and pulse-wave velocity

    Time frame: Before start of chemotherapy (1 hour after including in the trial)

    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.

  3. Evaluation of concetration of ENOS and Big Endothelin in blood sampling

    Time frame: Before start of chemotherapy (1 hour after including in the trial)

    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.

Secondary outcomes

  1. Evaluation of blood pressure

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

    Both systolic and diastiolic blood pressure was measured in the office in the seated position, noninvasively.

  2. Evaluation of flow-mediated vasodilation and pulse-wave velocity

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

    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.

  3. Evaluation of concetration of ENOS and Big Endothelin of blood sampling

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

    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.

Sponsors and collaborators

Lead sponsor

I.M. Sechenov First Moscow State Medical University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Dec 23, 2020
Registry last updated
Dec 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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