Cancer and Blood Pressure Management, CARISMA Study

  • STATUS
    Recruiting
  • participants needed
    60
  • sponsor
    ECOG-ACRIN Cancer Research Group
Updated on 5 February 2023
peripheral artery disease
cancer
hypertension
heart failure
myocardial infarction
infarct
acute coronary syndrome
coronary revascularization

Summary

This phase II trial studies how well intensive blood pressure management works in decreasing systolic blood pressure in patients with kidney or thyroid cancer that has spread to other places in the body (metastatic) who are starting anti-angiogenic tyrosine kinase inhibitor cancer therapy. This study is being done to find out if a systolic blood pressure to a target of less than 120 mmHg (intensive systolic blood pressure management) can be achieved, well tolerated, and beneficial as compared to the usual approach to a target of less than 140 mmHg while taking an anti-angiogenic tyrosine kinase inhibitor. This study may help doctors understand the best way to control blood pressure in kidney or thyroid cancer patients taking anti-angiogenic tyrosine kinase inhibitor.

Description

PRIMARY OBJECTIVE:

I. To determine the feasibility of an intensive (systolic blood pressure [SBP] < 120 mmHg) "Intervention" versus standard care (SBP < 140 mmHg) "Non-Intervention" approach to blood pressure (BP) control in metastatic renal cell and thyroid cancer patients initiating anti-angiogenic tyrosine kinase inhibitors.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM A: Patients receive intensive systolic blood pressure management for 6 months. Patients receive increased blood pressure medication every 2 weeks while systolic blood pressure is 120 mmHg or higher. Patients also monitor blood pressure at home 1 day a week (4 times in 1 day) every 2 weeks and upload the recorded blood pressure readings to the provider and to a central blood pressure monitoring team. Patients with changes in blood pressure medications monitor blood pressure readings on 3 days in 1 week (4 times in 1 day).

ARM B: Patients receive standard blood pressure management for 6 months. Patients receive blood pressure medications per doctor's instruction. Patients also monitor blood pressure at home 1 day (4 times in 1 day) every 2 weeks and upload the recorded blood pressures to a central monitoring team.

Details
Condition Cardiovascular Disorder, Chronic Kidney Disease, Metastatic Renal Cell Carcinoma, Metastatic Thyroid Gland Medullary Carcinoma, Stage IV Renal Cell Cancer AJCC v8, Stage IV Thyroid Gland Medullary Carcinoma AJCC v8, Stage IVA Thyroid Gland Medullary Carcinoma AJCC v8, Stage IVB Thyroid Gland Medullary Carcinoma AJCC v8, Stage IVC Thyroid Gland Medullary Carcinoma AJCC v8
Treatment questionnaire administration, quality-of-life assessment, Blood pressure measurement, Best Practice, clinical management
Clinical Study IdentifierNCT04467021
SponsorECOG-ACRIN Cancer Research Group
Last Modified on5 February 2023

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