Port Will be Flushed Every 3 Months Instead of Every 4-6 Wks, as Recommended by Port Manufacturer.
The purpose of this study is to evaluate the safety and effectiveness of port (PAC) flushes every 3 months rather than every four to six weeks.
It is routine practice to flush ports every four to six weeks, according to the manufacturer's recommendations, using salt solution followed heparin if needed. This study examines the effectiveness of port flushes at an alternative interval of 3 months, reducing the number of visits to the health-care provider.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Health Services Research
|Official Title:||Extended Interval Port Flushes: A Phase II Clinical Trial|
- Time to port complication [ Time Frame: Every 3 months for 1 year ] [ Designated as safety issue: Yes ]The short-term endpoint is time to port complication (EFP- event free port-complication). The long term end point will be time to port failure requiring removal of the port (OAP - overal port failure) and will be used to determine the efficacy of port flushes every 3 months.
- Frequency and severity of toxicity [ Time Frame: every three months ] [ Designated as safety issue: Yes ]Frequency and severity of toxicity will be monitored to describle incidence rates of toxicity.
- Cost effectiveness [ Time Frame: every three months ] [ Designated as safety issue: No ]Cost effectivenss will be estimated taking into consideration level of patient compliance and reduction in patient visits.
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||December 2016|
|Estimated Primary Completion Date:||December 2016 (Final data collection date for primary outcome measure)|
Experimental: 3-month flushing schedule
3-month port-flushing schedule
Other: Reduced port-flush schedule
This is a phase II, non-blinded, non-inferiority prospective cohort trial of patients with ports (PAC) after a systemic therapy to evaluate the safety and effectiveness of PAC flushes in 3 months intervals. Patients with any type of cancer are eligible. The study will extend 1 year from enrollment of the last patient. Each enrolled patient will have his or her port flushed five times in 3 month intervals.
Patients will be enrolled after the completion of systemic therapy and after completion of the restaging follow up, which is the time period from 4 weeks to 3 months after discontinuation of the chemotherapy. Once patients are enrolled to extended interval PAC flushes, they will be followed for one year. At the end of the year patients will return to standard PAC flushes. If patients experience any PAC malfunction, it would be considered a PAC failure and the flushing will reverted back to the schedule recommended by the manufacturer.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01047644
|Contact: Goetz H Kloecker, MDfirstname.lastname@example.org|
|Contact: Karen M Carter, BA, BSN||502-562-3429|
|United States, Kentucky|
|James Graham Brown Cancer Center||Recruiting|
|Louisville, Kentucky, United States, 40202|
|Contact: Goetz H Kloecker, MD 502-562-3429|
|Contact: Karen M Carter, BA, BSN 502-562-3429|
|Principal Investigator: Goetz H Kloecker, MD|
|Sub-Investigator: Dharamvir Jain, MD|
|Sub-Investigator: Vivek R Sharma, MD|
|Sub-Investigator: Elizabeth C Riley, MD|
|Sub-Investigator: Donald M Miller, MD, PhD|
|Sub-Investigator: Jason A Chesney, MD, PhD|
|Principal Investigator:||Goetz H Kloecker, MD||James Graham Brown Cancer Center, University of Louisville|