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

Mayo Clinic

Status and phase: Completed; Phase 2

Conditions: Unspecified Adult Solid Tumor, Protocol Specific; Vascular Access Device Complications

Treatments: Procedure: vascular access device placement

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00607880

P30CA015083 (U.S. NIH Grant/Contract)

52-04 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

Standard Port

Active Comparator group

Description:

Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy.

Treatment:

Procedure: vascular access device placement

Vortex Implantable Access Port

Experimental group

Description:

Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy.

Treatment:

Procedure: vascular access device placement