Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00607880
First received: February 1, 2008
Last updated: April 9, 2014
Last verified: April 2014
  Purpose

RATIONALE: Giving chemotherapy drugs through an implanted port reduces the need for multiple needle sticks. It is not yet known whether one type of port is more effective than another in reducing infections and other side effects associated with long-term port use.

PURPOSE: This randomized clinical trial is comparing two types of ports in patients with cancer receiving intravenous chemotherapy.


Condition Intervention Phase
Unspecified Adult Solid Tumor, Protocol Specific
Vascular Access Device Complications
Procedure: vascular access device placement
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Supportive Care
Official Title: A Prospective Randomized Study of the Vortex® Implantable Access Port Versus the BardPort™ Implantable Port in Cancer Patients Receiving Adjuvant Intravenous Chemotherapy

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Port Failure Within 12 Months of Port Insertion [ Time Frame: Up to 12 months from port insertion ] [ Designated as safety issue: Yes ]
    We report the proportion of patients in each treatment group who have some degree of port failure. Port failure is defined as the composite outcome of port malfunction due to partial or total occlusion and any infection related to the port, within 12 months of port insertion. The percentages reported here are the number of patients that had reported a port failure within 12 months out of the number of patients with port failure within 12 months plus the number of patients that were followed 12 months without port failure.


Secondary Outcome Measures:
  • Death From All Causes [ Time Frame: Up to 12 months after port insertion ] [ Designated as safety issue: Yes ]
    Number of patients that died during treatment due to any cause.

  • Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion [ Time Frame: Up to 12 months after port insertion ] [ Designated as safety issue: Yes ]
    We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months.

  • Termination of Use of the Indwelling Port at 12 Months After Port Insertion [ Time Frame: Up to 12 months after port insertion ] [ Designated as safety issue: Yes ]
    The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.


Enrollment: 100
Study Start Date: June 2004
Study Completion Date: March 2009
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Standard Port
Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.
Procedure: vascular access device placement
Experimental: Vortex Implantable Access Port
Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.
Procedure: vascular access device placement

Detailed Description:

OBJECTIVES:

Primary

  • To compare the rate of port failure, defined as the occurrence of port malfunction or port infection within 12 months after port insertion, in patients with cancer requiring long-term adjuvant intravenous chemotherapy undergoing insertion of a newly designed, FDA-approved Vortex® implantable vascular access port vs a conventional vascular access port.

Secondary

  • To compare the rate of port malfunction or port infection at 6 and 12 months after port insertion.
  • To compare the rate of central vein thrombosis at 6 and 12 months after port insertion.
  • To compare the rate of port removal for any reason other than infection or occlusion at 6 and 12 months after port insertion.
  • To compare the rate of termination of use of the indwelling port at 6 and 12 months after port insertion.
  • To compare the death from all causes.
  • To compare the incidence of port-related interventions at 6 and 12 months after port insertion.

OUTLINE: Patients are randomized to 1 of 2 intervention arms.

  • Arm I: Patients undergo insertion of a conventional vascular access port. Patients then receive standard chemotherapy.
  • Arm II : Patients undergo insertion of the Vortex® implantable vascular access port. Patients then receive standard chemotherapy.

All episodes of access to the port are documented for 12 months after port insertion. Information including the reason for port access and difficulty in access is collected. Complications, such as occlusion and infection, implant duration, and incidence of port-related interventions are assessed at 6 and 12 months after port insertion.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

DISEASE CHARACTERISTICS:

  • Diagnosis of malignancy requiring intravenous chemotherapy for ≥ 6 months

    • Must undergo entire course of chemotherapy at the Mayo Clinic in Jacksonville, unless the outside treating institution agrees to submit the research data sheet to Mayo Clinic
  • Scheduled time frame for regular use of the vascular access port ≥ 3 months after port insertion

PATIENT CHARACTERISTICS:

  • Life expectancy ≥ 6 months
  • No active skin condition implicating an elevated risk of local or systemic infectious or non-infectious complications, including any of the following:

    • Current skin infection
    • Cutaneous lymphoma
    • Auto-immune disorders
    • Active vasculitis
    • Connective tissue diseases
  • No known active infection requiring antibiotic therapy at the time of port implantation

    • Patients without an active infection who are on chronic antibiotic suppressive therapy are eligible
  • No concurrent illness requiring chronic anticoagulation

    • Patients who develop other comorbidities requiring chronic anticoagulation during the study period are eligible

PRIOR CONCURRENT THERAPY:

  • See Disease Characteristics
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00607880

Locations
United States, Florida
Mayo Clinic - Jacksonville
Jacksonville, Florida, United States, 32224
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Albert G. Hakaim, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Mayo Clinic
ClinicalTrials.gov Identifier: NCT00607880     History of Changes
Other Study ID Numbers: P30CA015083, P30CA015083, 52-04
Study First Received: February 1, 2008
Results First Received: April 9, 2014
Last Updated: April 9, 2014
Health Authority: United States: Federal Government

Keywords provided by Mayo Clinic:
vascular access device complications
unspecified adult solid tumor, protocol specific

ClinicalTrials.gov processed this record on September 16, 2014