Clinical trial NCT00607880: Study Comparing Two Types of Ports in Patients With Cancer Receiving Intravenous Chemotherapy
Official title: A Prospective Randomized Study of the Vortex® Implantable Access Port Versus the BardPort™ Implantable Port in Cancer Patients Receiving Adjuvant Intravenous Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Unspecified Adult Solid Tumor, Protocol Specific
Vascular Access Device Complications
Keywords: vascular access device complications
unspecified adult solid tumor, protocol specific
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2008-02-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: Port Failure Within 12 Months of Port Insertion
timeFrame: Up to 12 months from port insertion
Secondary outcomes:
measure: Death From All Causes
timeFrame: Up to 12 months after port insertion
measure: Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
timeFrame: Up to 12 months after port insertion
measure: Termination of Use of the Indwelling Port at 12 Months After Port Insertion
timeFrame: Up to 12 months after port insertion
Other outcomes:
Locations:
city: Jacksonville
country: United States
facility: Mayo Clinic - Jacksonville
state: Florida
Study officials:
affiliation: Mayo Clinic
name: Albert G. Hakaim, MD
role: PRINCIPAL_INVESTIGATOR
References: