NCT04467021

Cancer and Blood Pressure Management, CARISMA Study

Cancer Therapy Risk-Reduction With Intensive Systolic BP Management (CARISMA) - a Phase II Study

• Status: Active Not Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 61 (actual)
• Sponsor: ECOG-ACRIN Cancer Research Group · Network
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• 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

Interventions

Type	Name	Description
OTHER	Best Practice	Receive usual blood pressure management
OTHER	Blood Pressure Measurement	Undergo blood pressure measurement
OTHER	Clinical Management	Undergo intensive systolic BP management
OTHER	Quality-of-Life Assessment	Ancillary studies
OTHER	Questionnaire Administration	Ancillary studies

Timeline

• Start date: 2020-10-29
• Primary completion: 2026-08-31
• Completion: 2026-08-31
• First posted: 2020-07-10
• Last updated: 2026-04-03

Locations

25 sites across 1 country: United States