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Blood Pressure Management for Kidney and Thyroid Cancer

N/A

Waitlist Available

Led By Bonnie Ky

Research Sponsored by ECOG-ACRIN Cancer Research Group

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Patient with a history of hepatitis C virus (HCV) infection must have been treated and cured

Patient must have either clinical cardiovascular (CV) disease or evidence of increased CV risk

Must not have

Uncontrolled blood pressure defined by SBP > 160 mmHg on three or more antihypertensives prior to TKI initiation

Women of childbearing potential with a positive pregnancy test

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 6 months

Awards & highlights

No Placebo-Only Group

Summary

This trial looks at the effects of intensive blood pressure management in patients with metastatic kidney or thyroid cancer who are starting anti-angiogenic therapy.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects may include changes in blood pressure levels due to the intensive management approach. The study does not introduce new medications but focuses on managing existing treatment side effects more aggressively.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I had hepatitis C but have been treated and cured.

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I have heart disease or am at high risk for heart problems.

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My kidney function is reduced but not severely (moderate CKD).

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My cancer is advanced kidney or thyroid cancer treated first with specific cancer drugs.

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My hepatitis B virus load is undetectable with treatment.

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I can take care of myself and am up and about more than half of my waking hours.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I am of childbearing age and my pregnancy test is positive.

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I have severe kidney issues, including dialysis, high potassium, a transplant, or very low filtration rate.

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I haven't had major heart issues, strokes, severe bleeding, or lung clots in the last 3 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Bronchial Provocation Tests

Secondary study objectives

Bronchial Provocation Tests

Pharmaceutical Preparations

Differences in symptoms and health-related quality of life

+4 more

Other study objectives

Incidence of significant cardiovascular (CV) events

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

0 / 10Eligibility criteria met