Clinical trial NCT04681560: Impact of Platinum-based Cancer Treatment on Endothelial Function
Official title: The Effect of Polychemotherapy on Endothelial Function Ans Vessel Age in Cancer Patients.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Blood Pressure
Cardiovascular Complication
Lead sponsor: I.M. Sechenov First Moscow State Medical University
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
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.

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Evaluation of blood pressure
timeFrame: Before start of chemotherapy (1 hour after including in the trial)
measure: Evaluation of flow-mediated vasodilation and pulse-wave velocity
timeFrame: Before start of chemotherapy (1 hour after including in the trial)
measure: Evaluation of concetration of ENOS and Big Endothelin in blood sampling
timeFrame: Before start of chemotherapy (1 hour after including in the trial)
Secondary outcomes:
measure: Evaluation of blood pressure
timeFrame: In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
measure: Evaluation of flow-mediated vasodilation and pulse-wave velocity
timeFrame: In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
measure: Evaluation of concetration of ENOS and Big Endothelin of blood sampling
timeFrame: In range of 3 -12 weeks after start of chemotherapy (before next chepotherapy drug injection)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
facility: Olga Andreeva
city: Moscow
country: Russian Federation
facility: First Moscow State Medical University.
Study officials:
affiliation: I.M. Sechenov First Moscow State Medical University
name: Dmitry Shchekochikhin, PhD
role: PRINCIPAL_INVESTIGATOR
References: