Impact of Platinum-based Cancer Treatment on Endothelial Function

High Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04681560
• Other study ID #: 1019
• Status: Completed
• Start date: January 18, 2018
• Est. completion date: January 20, 2020

Study information

• Verified date: September 2019
• Source: I.M. Sechenov First Moscow State Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: January 20, 2020
• Est. primary completion date: December 9, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cardiovascular Complication
• High Blood Pressure
• Hypertension

Locations

Country	Name	City	State
Russian Federation	First Moscow State Medical University.	Moscow
Russian Federation	Olga Andreeva	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)
Primary	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)
Primary	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	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)
Secondary	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)
Secondary	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)