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OpenTrials
Completed

NCT Number: NCT01047644

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.

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Key information

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

James Graham Brown Cancer Center

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Minors, prisoners
  • Previous PAC failure
  • Disease recurrence
  • Patients who had their PAC removed immediately following therapy.

Treatment and study plan

Reduced port-flush schedule

Other

3-month port-flushing

Primary outcomes

  1. Time to port complication

    Time frame: Every 3 months for 1 year

    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.

Secondary outcomes

  1. Frequency and severity of toxicity

    Time frame: every three months

    Frequency and severity of toxicity will be monitored to describle incidence rates of toxicity.

  2. Cost effectiveness

    Time frame: every three months

    Cost effectivenss will be estimated taking into consideration level of patient compliance and reduction in patient visits.

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • James Graham Brown Cancer Center

Registry information

Official study title

Extended Interval Port Flushes: A Phase II Clinical Trial

Important dates

Study start
2009
Primary completion
2017
Study completion
2017
First posted
Jan 13, 2010
Registry last updated
Jul 19, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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