Active — Not RecruitingNot Applicable

Cancer and Blood Pressure Management, CARISMA Study

United States61 participantsStarted 2020-10-29

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * English speaking * Patient must have histologically or cytologically-proven advanced metastatic renal cell cancer (mRCC) or medullary thyroid cancer initially treated with anti-angiogenic tyrosine kinase inhibitors (AA-TKIs) including: sunitinib, sorafenib, pazopanib, cabozantinib, lenvatinib, vandetanib, or axitinib) * NOTE: If patient has a severe sulfa allergy (e.g. Stevens Johnson reaction), then alternative non-sulfa medications can be considered in consultation with the C-BAC. Patient with a noted severe allergic reactions to medications listed in the algorithms is not necessarily excluded from this trial, as alternative medications could be considered in consultation with the C-BAC. Moreover, the patient treated with pre-existing medications that may interact with proposed BP medications is not necessarily excluded, as alternative medications exist. The clinical significance of any potential drug interactions can also be addressed with the C-BAC. * Prior exposure to another AA-TKI is permissible. Concurrent or prior treatment with immunotherapy is also permissible * Patient must have either clinical cardiovascular (CV) disease or evidence of increased CV risk as defined by one or more of the following: * Clinical CV disease (history of myocardial infarction \[MI\] acute coronary syndrome, coronary revascularization, carotid endarterectomy or stenting greater than 3 months prior to registration, peripheral artery disease, cerebrovascular acc…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is actively enrolling but no longer recruiting new patients — does that mean it's too late for me to join, or is there any chance my doctor could still look into whether I might be eligible?
2Since this study is focused on measuring differences in systolic blood pressure rather than testing a new cancer drug, how would participating actually benefit my cancer care, and would it change any of my current treatment decisions?
3Given that I have metastatic renal cell carcinoma or medullary thyroid carcinoma alongside the cardiovascular concerns this study is tracking, is my blood pressure already being monitored closely enough as part of my standard oncology care, or would a study like this add something meaningful?
4The trial is listed as phase NA, which suggests it may be more of an observational or management study rather than a treatment trial — can you help me understand what that means for how my safety and health outcomes would be protected if I were somehow still able to participate?
5If I already have chronic kidney disease on top of my cancer diagnosis, how might that affect the way my blood pressure needs to be managed, and is there guidance from studies like this one that you're already applying to my care?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Differences in systolic blood pressure (SBP) based on automated office BP measurements

Timeframe: Up to 6 months

Trial details

NCT IDNCT04467021

SponsorECOG-ACRIN Cancer Research Group

Sponsor typeNETWORK

Study typeINTERVENTIONAL

Primary completion2026-08-31

View on ClinicalTrials.gov More Cardiovascular Disorder trials