Dental Study in Cancer Patients With Central Venous Catheters (NCT00798330) | Clinical Trial Compass
CompletedNot Applicable
Dental Study in Cancer Patients With Central Venous Catheters
United States27 participantsStarted 2012-09
Plain-language summary
Patients who are preparing to receive chemotherapy are asked to have their teeth cleaned before starting treatment as standard of care. This research study is being done to see if having dental cleaning increases the chances of bacteria from the mouth getting into the blood stream. It is also being done to see if these bacteria can cause blood stream infections in people who have a Central Venous Catheter (CVC),often called a "port" or a "PICC", placed for giving chemotherapy. It is a well-established fact that we introduce bacteria from the mouth into the bloodstream with activities of daily life including chewing, flossing and brushing teeth. This introduction of bacteria into the blood stream may cause bacteria to stick to the central venous catheter and serve as a source of infection when the immune system is weakened by cancer. The purpose of this research study is to see if we can find bacteria from mouth in blood that is drawn through the CVC, during, and after a dental cleaning procedure. This way, we will be able to assess whether or not this is a potential health risk to cancer patients.
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
* Patients willing and able to provide written informed consent for the study.
* Patients diagnosed with cancer and being treated at the University of Connecticut Health Center.
* Patients scheduled to receive or who have received a central venous catheter
* Patients who have at least one tooth.
Exclusion criteria
* Patients under the age of 18
* Patients who have received any antibacterial in the time period starting 48 hours before the dental cleaning. This includes systemic antibacterials and topical antibacterials in the oral cavity or at/through the CVC site. (Topical antibacterials at other sites are allowed; antifungal and antiviral agents in any form are allowed).
* Patients who plan to use antibacterials within the 24 hours after the procedure (until the final blood sample is obtained).
* Patients with a documented blood stream infection within 1 month prior to proposed dental cleaning.
* Patients with a clinically significant coagulation disorder or patients on warfarin.
* Patients who require antibiotic prophylaxis as per American College of Cardiology/American Heart Association (ACC/AHA) 2007 guidelines, namely;
* patients who have had a cardiac transplantation,
* incomplete cardiac valve repair,
* complete cardiac valve repair in last 6 months,
* prior history of infective endocarditis ,
* patients with a prosthetic cardiac valve.
* Patients with any other condition which might preclude participation in the opinion of the patient's physician…
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.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
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
1
To determine the incidence of transient bacteremia and established blood-stream infections (BSIs) by oral microorganisms in cancer patients with CVCs after an invasive dental procedure