Unspecified Adult Solid Tumor, Protocol Specific, Vascular Access Device Complications
Conditions
Keywords
vascular access device complications, unspecified adult solid tumor, protocol specific
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.
Interventions
PROCEDUREvascular access device placement
Sponsors
National Cancer Institute (NCI)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Port Failure Within 12 Months of Port Insertion | Up to 12 months from port insertion | 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
| Measure | Time frame | Description |
|---|---|---|
| Death From All Causes | Up to 12 months after port insertion | 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 | Up to 12 months after port insertion | 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 | Up to 12 months after port insertion | The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint. |
Countries
United States
Participant flow
Recruitment details
All patients considered for port implantation for intravenous chemotherapy were consulted and evaluated for port implantation. This evaluation was not study specific. If the implantation of a port system was feasible, the patient fulfilled inclusion criteria and the patient consented to the study, then they were randomly assigned a treatment port.
Pre-assignment details
One patient in the Standard Access Port group was unable to have the port placed due to chronic left internal jugular occlusion and was excluded from the analyses.
Participants by arm
| Arm | Count |
|---|---|
| Standard Access Port Patients undergo insertion of the conventional vascular access port (C. R. Bard, Inc., Murray Hill, NJ). Patients then receive standard chemotherapy. | 50 |
| Vortex Implantable Access Port Patients undergo insertion of the Vortex® implantable vascular access port (Horizon Medical Products, Manchester, GA). Patients then receive standard chemotherapy. | 50 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Unable to place port due to occlusion | 1 | 0 |
Baseline characteristics
| Characteristic | Standard Access Port | Vortex Implantable Access Port | Total |
|---|---|---|---|
| Age, Continuous | 65 years | 64 years | 65 years |
| Region of Enrollment United States | 50 participants | 50 participants | 100 participants |
| Sex: Female, Male Female | 21 Participants | 24 Participants | 45 Participants |
| Sex: Female, Male Male | 29 Participants | 26 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 49 | 0 / 50 |
| serious Total, serious adverse events | 5 / 49 | 4 / 50 |
Outcome results
Primary
Port Failure Within 12 Months of Port Insertion
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.
Time frame: Up to 12 months from port insertion
Population: Patients with port failure within 12 months and patients that were followed 12 months without port failure were included in this analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Access Port | Port Failure Within 12 Months of Port Insertion | 16.1 percentage of patients |
| Vortex Implantable Access Port | Port Failure Within 12 Months of Port Insertion | 13.8 percentage of patients |
Secondary
Death From All Causes
Number of patients that died during treatment due to any cause.
Time frame: Up to 12 months after port insertion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Access Port | Death From All Causes | 9 participants |
| Vortex Implantable Access Port | Death From All Causes | 6 participants |
Secondary
Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion
We report the number of patients that terminated use of port due to any reason other than infection or occlusion within 12 months.
Time frame: Up to 12 months after port insertion
Population: All patients accrued to this study that had their port removed within12 months for any reason other than infection/occlusion were included in this analysis. 28 patients using the Standard Access Port and 30 patients using the Vortex Implantable Access Port had port removal prior to 12 months due to reasons other than infection or occlusion..
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Standard Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Death | 9 participants |
| Standard Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Unknown | 5 participants |
| Standard Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | End of Chemotherapy | 7 participants |
| Standard Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Skin Erosion | 1 participants |
| Standard Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Unhealed Incision | 1 participants |
| Standard Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Thrombosis | 0 participants |
| Standard Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Patient Moved/Transferred Care | 4 participants |
| Standard Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Patient Request | 1 participants |
| Vortex Implantable Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Skin Erosion | 0 participants |
| Vortex Implantable Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Patient Request | 0 participants |
| Vortex Implantable Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Thrombosis | 1 participants |
| Vortex Implantable Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Unknown | 10 participants |
| Vortex Implantable Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Death | 6 participants |
| Vortex Implantable Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Unhealed Incision | 0 participants |
| Vortex Implantable Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | End of Chemotherapy | 6 participants |
| Vortex Implantable Access Port | Port Removal for Any Reason Other Than Infection or Occlusion Within 12 Months After Port Insertion | Patient Moved/Transferred Care | 7 participants |
Secondary
Termination of Use of the Indwelling Port at 12 Months After Port Insertion
The number of patients that discontinued use of inserted port for any reason at the 12 month timepoint.
Time frame: Up to 12 months after port insertion
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Standard Access Port | Termination of Use of the Indwelling Port at 12 Months After Port Insertion | 31 participants |
| Vortex Implantable Access Port | Termination of Use of the Indwelling Port at 12 Months After Port Insertion | 31 participants |