Blood Pressure Management for Kidney and Thyroid Cancer

Recruiting in Palo Alto (17 mi)

+25 other locations

Overseen byBonnie Ky

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: ECOG-ACRIN Cancer Research Group

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

This trial is for adults with metastatic kidney or thyroid cancer who are starting anti-angiogenic tyrosine kinase inhibitor therapy. They must have cardiovascular disease or risk, chronic kidney disease with specific blood filtration rates, and controlled hepatitis if present. Participants need to be able to monitor their blood pressure at home, use contraception if necessary, and have internet access.

Inclusion Criteria

Must have internet access through a computer, tablet, or smart phone to use EASEE-PRO and home BP monitoring

Your blood pressure is consistently higher than 130 mmHg when measured multiple times.

I had hepatitis C but have been treated and cured.

+15 more

Exclusion Criteria

I have not had brain surgery or radiotherapy in the last 2 weeks.

Pregnant or breast-feeding women

My blood pressure is high despite taking three or more blood pressure medications.

+4 more

Participant Groups

The CARISMA study is testing whether intensive management of systolic blood pressure (target less than 120 mmHg) using home monitoring and medication adjustments provides benefits over usual care (target less than 140 mmHg) in patients taking cancer drugs that inhibit blood vessel growth.

2Treatment groups

Experimental Treatment

Active Control

Group I: Arm A (intensive systolic blood pressure management)Experimental Treatment4 Interventions

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).

Group II: Arm B (usual blood pressure management)Active Control3 Interventions

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.