Blood Pressure Management for Kidney and Thyroid Cancer

Not currently recruiting at 29 trial locations

Overseen By Bonnie Ky, MD, MSCE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: ECOG-ACRIN Cancer Research Group

Must be taking: Anti-hypertensives

Must not be taking: Angiotensin receptor blockers

Disqualifiers: Dialysis, Recent stroke, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if more intensive blood pressure management can benefit patients with kidney or thyroid cancer, particularly when the cancer has metastasized and they are beginning a specific cancer treatment. The goal is to lower blood pressure to less than 120 mmHg and compare it to the usual target of less than 140 mmHg. The study includes two groups: one with regular blood pressure management and another with the intensive approach. It suits individuals with kidney or thyroid cancer who are undergoing certain treatments and have high blood pressure (130 mmHg or more). Participants must be willing to monitor their blood pressure at home and have internet access. As an unphased trial, this study provides a unique opportunity to contribute to understanding the benefits of intensive blood pressure management for cancer patients.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that if you are on medications that might interact with the trial's blood pressure medications, alternative options can be considered. It's best to discuss your specific medications with the trial team.

What prior data suggests that intensive blood pressure management is safe for patients with metastatic kidney or thyroid cancer?

Research has shown that carefully managing blood pressure can be safe for patients, including those with cancer. Studies have found that controlling blood pressure can lower the risk of heart problems without causing kidney issues. Specifically, one study found that it reduced heart risks in cancer survivors, suggesting this approach might be well-tolerated.

Additionally, another study found that early increases in blood pressure during cancer treatment with certain drugs were not linked to major heart problems. This suggests that careful blood pressure management might not cause serious issues for patients starting cancer therapy. Overall, current research supports that careful blood pressure management can be safe and helpful for patients, including those receiving cancer treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the intensive blood pressure management approach for kidney and thyroid cancer patients because it could offer a more precise way to control blood pressure. Unlike standard methods that follow a routine medication schedule, this approach intensively adjusts medication every two weeks until systolic blood pressure drops below 120 mmHg. This method involves frequent home monitoring, allowing for real-time adjustments and potentially leading to better blood pressure control. By tailoring the treatment to individual needs, researchers hope this strategy will improve patient outcomes and provide insights into managing blood pressure more effectively for those with cancer.

What evidence suggests that intensive blood pressure management is effective for metastatic kidney or thyroid cancer patients?

This trial will compare two approaches to blood pressure management for patients with kidney or thyroid cancer. Participants in Arm A will receive intensive systolic blood pressure management, targeting below 120 mmHg. Research has shown that closely managing blood pressure can significantly lower systolic blood pressure. Studies have found that controlling blood pressure reduces the risk of serious heart issues in cancer patients. For those with kidney or thyroid cancer, careful blood pressure management may also mitigate the side effects of certain cancer drugs, which can cause blood pressure to rise. Keeping it low might improve overall treatment outcomes. Participants in Arm B will receive usual blood pressure management, with a target of 140 mmHg. Early research suggests that aiming for a systolic blood pressure below 120 mmHg is safe and more beneficial than the usual target of 140 mmHg. ^{1 2 3 4 6}

Who Is on the Research Team?

Bonnie Ky

Principal Investigator

ECOG-ACRIN Cancer Research Group

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either intensive or standard systolic blood pressure management for 6 months. Intensive management involves increased medication every 2 weeks if SBP is 120 mmHg or higher, with home monitoring and data uploads.

6 months

Bi-weekly home monitoring and data uploads

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of symptoms, quality of life, and satisfaction with blood pressure care.

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Intensive Blood Pressure Management

Trial Overview

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.

How Is the Trial Designed?

Group I: Arm A (intensive systolic blood pressure management) Experimental Treatment 4 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 Control 3 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.

Who Is Running the Clinical Trial?

ECOG-ACRIN Cancer Research Group

Lead Sponsor

Trials

122

Recruited

160,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

In a study of 143 cancer patients with elevated blood pressure, over half had controlled cancer but more than a third were not receiving treatment, indicating a potential opportunity for hypertension management in this group.

Only 9% of patients received specific discharge instructions for hypertension follow-up, highlighting a gap in care that could be addressed in emergency settings to improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hypertension in cancer patients seeking acute care: an opportunity to intervene. Escalante, CP., Weiser, MA., Lam, T., et al.[2019]

Managing hypertension in patients with kidney disease often requires a combination of at least three antihypertensive medications, including an ACE inhibitor and a diuretic, to meet recommended blood pressure goals of <130/85 mmHg.

Despite treatment efforts, only 11% of patients with diabetic kidney disease achieve these blood pressure targets, highlighting the need for improved physician education and patient awareness to prevent the progression of kidney disease and the need for dialysis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment of hypertension in patients with renal disease. Garg, J., Bakris, GL.[2019]

Citations

1.

jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2836388

Intensive Systolic Blood Pressure Reduction and Kidney ...

These findings suggest that intensive blood pressure control reduced the incidence of composite cardiovascular disease without increasing the risk of kidney ...

2.

clinicaltrials.gov

clinicaltrials.gov/study/NCT04467021?titles=Cancer%20Therapy%20Risk-Reduction%20with%20Intensive%20Systolic%20BP%20Management%20&rank=1

Cancer and Blood Pressure Management, CARISMA Study

This phase II trial studies how well intensive blood pressure management works in decreasing systolic blood pressure in patients with kidney or thyroid ...

3.

ahajournals.org

ahajournals.org/doi/10.1161/HYPERTENSIONAHA.123.22194

Effect of Intensive Blood Pressure Control on ...

In SPRINT study, intensive blood pressure treatment reduced the risk of major cardiovascular events in cancer survivors to a similar extent to that of patients ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12441609/

Cardiovascular Risk Assessment in Patients With Kidney ...

The results suggest that CV death becomes dominant over RCC death during survivorship, especially so for patients with stage 1 RCC. Deng et al ...

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/37856199/

Early Increases in Blood Pressure and Major ... - PubMed

Early Increases in Blood Pressure and Major Adverse Cardiovascular Events in Patients With Renal Cell Carcinoma and Thyroid Cancer Treated With VEGFR TKIs.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10695474/

Early Increases in Blood Pressure and Major Adverse ...

Early significant elevations of SBP or DBP during the first 4 weeks following VEGFR TKI initiation were not significantly associated with adverse CV outcomes ...