Cancer and Blood Pressure Management, CARISMA Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- 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
- Type
- Interventional
- Phase
- Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: None (Open Label)Primary Purpose: Treatment
Participation Requirements
- Age
- Between 18 years and 125 years
- Gender
- Both males and females
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-angiogeni...
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.
Tracking Information
- NCT #
- NCT04467021
- Collaborators
- National Cancer Institute (NCI)
- Investigators
- Principal Investigator: Bonnie Ky ECOG-ACRIN Cancer Research Group
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