Clinical trial NCT01047644: Port Will be Flushed Every 3 Months Instead of Every 4-6 Wks, as Recommended by Port Manufacturer.
Official title: Extended Interval Port Flushes: A Phase II Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Complication of Catheter
Keywords: port
catheter
infusion
flush
cleanse
chemotherapy
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: James Graham Brown Cancer Center
First posted: 2010-01-13
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. All patients 18 years and older with solid or hematological tumor who have a PAC after completion of curative intent treatment (Chemotherapy/Biotherapy)
2. Without active disease
3. Able to give informed consent

Exclusion Criteria:

1. Minors, prisoners
2. Previous PAC failure
3. Disease recurrence
4. Patients who had their PAC removed immediately following therapy.

Primary outcomes:
measure: Time to port complication
timeFrame: Every 3 months for 1 year
Secondary outcomes:
measure: Frequency and severity of toxicity
timeFrame: every three months
measure: Cost effectiveness
timeFrame: every three months
Other outcomes:
Locations:
city: Louisville
country: United States
facility: James Graham Brown Cancer Center
state: Kentucky
Study officials:
affiliation: James Graham Brown Cancer Center, University of Louisville
name: Goetz H Kloecker, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Diaz JA, Rai SN, Wu X, Chao JH, Dias AL, Kloecker GH. Phase II Trial on Extending the Maintenance Flushing Interval of Implanted Ports. J Oncol Pract. 2017 Jan;13(1):e22-e28. doi: 10.1200/JOP.2016.010843. Epub 2016 Oct 23.