Blood Pressure Management for Kidney and Thyroid Cancer

Recruiting at 25 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

61 Participants Needed

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.

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 data supports the effectiveness of the treatment Intensive Blood Pressure Management for kidney and thyroid cancer?

In patients with kidney cancer treated with antiangiogenic therapy, those who developed high blood pressure showed a better response to treatment and longer periods without disease compared to those who did not experience increased blood pressure. This suggests that managing blood pressure could be important for improving treatment outcomes in these patients. ^{1 2 3 4 5}

Is intensive blood pressure management safe for humans?

Managing blood pressure is generally safe, but treatments like lenvatinib and sunitinib, used for thyroid and kidney cancer, can cause high blood pressure. It's important to monitor and manage blood pressure carefully during treatment to avoid complications. ^{2 6 7 8 9}

How does intensive blood pressure management differ from other treatments for kidney and thyroid cancer?

Intensive blood pressure management focuses on achieving lower blood pressure targets to protect kidney function and reduce cardiovascular risks, which is particularly important for patients with chronic kidney disease. This approach may involve using multiple medications to reach specific blood pressure goals, unlike standard treatments that might not target such aggressive blood pressure control. ^{10 11 12 13 14}

Research Team

Bonnie Ky

Principal Investigator

ECOG-ACRIN Cancer Research Group

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.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Resistance to antihypertensive drugs targeting Renin-Angiotensin-Aldosterone-System in cancer patients: a case series. [2020]

2. Argentina pubmed.ncbi.nlm.nih.gov

[Hypertension as predictive factor in renal cell cancer treated with antiangiogenic therapy]. [2011]

3. United States pubmed.ncbi.nlm.nih.gov

Blood Pressure Classification Using the 2017 ACC/AHA Guideline and Heart Failure in Patients With Cancer. [2023]

4. United States pubmed.ncbi.nlm.nih.gov

Hypertension in cancer patients seeking acute care: an opportunity to intervene. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

[Relationship of renal cell carcinoma and hypertension]. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Blood pressure and risk of renal cell carcinoma in the European prospective investigation into cancer and nutrition. [2022]

7. United States pubmed.ncbi.nlm.nih.gov

Association between baseline blood pressure and the incidence of lenvatinib-induced hypertension in patients with thyroid cancer. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Diagnosis and management of hypertension in advanced renal cell carcinoma: prospective evaluation of an algorithm in patients treated with sunitinib. [2018]

9. United States pubmed.ncbi.nlm.nih.gov

Use of multikinase inhibitors/lenvatinib in patients with high cardiovascular risk/vasculopathy and radioiodine refractory-differentiated thyroid cancer. [2023]

10. Japan pubmed.ncbi.nlm.nih.gov

Blood pressure control in patients with chronic kidney disease. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

What is the ideal blood pressure goal for patients with stage III or higher chronic kidney disease? [2021]

12. Italy pubmed.ncbi.nlm.nih.gov

The 2018 ESC/ESH hypertension guidelines: Should nephrologists always stop at the lower boundary? [2021]

13. France pubmed.ncbi.nlm.nih.gov

[What is the goal blood pressure in non-diabetic chronic kidney disease?] [2019]

14. United States pubmed.ncbi.nlm.nih.gov

Treatment of hypertension in patients with renal disease. [2019]