Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05084040 |
| Other study ID # |
2663-19 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
September 15, 2021 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
September 2021 |
| Source |
AC Camargo Cancer Center |
| Contact |
Jose Luiz Gasparini-Jr, RN, MSc |
| Phone |
+5511972873514 |
| Email |
jose.gasparini[@]accamargo.org.br |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Abstract: Antineoplastic therapy (AT) is one of the most used treatment modalities to fight
cancer, either curatively or palliatively. There are several possible routes of
administration, but the intravenous is the most used for its safe absorption and maintenance
of the drug's serum level (1). Among the central catheters used in oncology, the long-term
Totally Implantable (CTI) catheter is one of the most well accepted by patients and
healthcare professionals. Being used in the administration of fluids, medication, parenteral
nutrition or to obtain blood. Maintaining the CTI is essential to maintain its permeability,
and thus, its proper functioning (2-4). The COVID-19 pandemic requires several readjustments
from health institutions to ensure healthy environments for patients and less exposure to the
hospital environment, one of the measures to focus on increasing the maintenance time of the
ICU from 30 to 60 days. Objective: To verify the safety of increasing the maintenance
interval of the Port-a-Cath catheter from 30 to 60 days through the rate of infection,
obstruction, dysfunction in the infusion of solutions and blood reflux at the end of a year
of follow-up. Method: This is an observational study, a single research arm, with a scheduled
duration from January 2021 to August 2022 at the chemotherapy clinics of the A.C.Camargo
Cancer Center. Expected results: This investigation is expected to demonstrate that
maintenance with saline every 60 days does not increase obstruction or infection in patients
who are in clinical follow-up compared to maintenance for 30 days.
Description:
1.Patients and methods
1.1. Study design
Recruitment will take place during three months in the chemotherapy ambulatory at A.C.
Camargo Cancer Center. Patients will be invited to participate in this study once they
undergo maintenance of the fully implanted catheter (FIC), according to institutional
routine. If the invited patient meets the inclusion and exclusion criteria defined in this
study, he will respond to the financial assessment (Appendix 1). In the next step, he will be
instructed to wait for the researcher to contact him to inform the next day of catheter
maintenance.
After the clinical findings and randomization assessment, the patient will be informed to
which group he belongs and he will be responsible for scheduling the next maintenance
appointment, according to the group to which he belongs.
The study researcher will be responsible for checking if all participants have planned and
carried out their maintenance according to his group. He will make sure that they underwent
the catheter maintenance in the recommended time period. The study will consist of two arms,
with the control group consisting of patients undergoing catheter care every 60 days as
recommended in the current institutional protocol. The experimental group will consist of
patients who will have a maintenance every 90 days.
Patients will be followed up for one year, with those randomized to the control group having
6 appointments and the experimental group having 4 appointments, in addition to the
recruitment period. During follow-up, nurses responsible for this procedure will evaluate the
development of specific mechanical complications related to the catheter. A graduated scale
of 1 to 5 will be applied: Grade 1 - no resistance to saline infusion with venous return;
Grade 2 - no resistance to saline infusion without venous return; Grade 3 - resistance to
saline infusion with venous return; Grade 4 - resistance to saline infusion without venous
return; Grade 5 - inability to infuse saline without venous return (obstructed). This rating
will be recorded on the puncture procedure form already available in the health sector.
In the patient´s cases that will present obstruction in the totally implanted catheter, they
will be forwarded to the emergency service. So, the medical teams will evaluate them to
verify any possibility to use tissue plasminogen activator (t-PA). In cases of catheter
infection, the patient will follow the institutional routine guide of treatment. The puncture
procedure will follow the institutional pattern that was validated with the Hospital
Infection Control Service.
1.2. Data assessment This study is expected to enrol 410 patients, 205 in the control group
and 205 in the experimental group. This evaluation will be performed using the power test
with 80% , significance level of 5%, and a rate of 1.35% in obstruction in the control group
based on a retrospective study (8) and 2.0% of obstruction in the experimental group with
study margin of 2.5% (14).
There are no studies indicating the obstruction rate for the experimental group, so an
estimate was made to find the calculated values. If the volume was not collected in the first
few months as planned, recruitment may be extended to the two years of this study, during
which time as many patients as possible will be recruited.
In the randomization, sequential allocation will be applied (15). As a confusing variable,
will be controlled gender and age. As a tool of randomization, an institutional website will
be used https://estatsaude.shinyapps.io/alocacao/.
All patients have "intention to treat" and they will be analyzed in the groups they were in
until the end of this study. Patients who have more than one event will be counted in each
event of the analysis. After data collection, a descriptive analysis will be made. Then the
absolute frequency of distribution and relative for qualitative variables and the main
measures such as mean, median, and standard deviation and minimum and maximum for
quantitative variables.
In order to evaluate a possible association between two qualitative variables, the
independence test ( Chi-Square Test or Fisher's exact test) will be used. To compare
quantitative variables concerning two independent groups, a non-parametric test of
Mann-Whitney or T-test will be used.
Logistic regression models will be applied to evaluate association with clinical and
socioeconomic variables of groups between those who will presented or not will presented
obstruction of infection of the catheter. The adopted level of significance will be of 5% and
the SPSS® for Windows® program, version 22.0 will be used.
1.3. Expected Results This study aims to demonstrate that saline maintenance every 90 days
compared with 60-days maintenance does not result in more obstructions or infections in
patients undergoing clinical follow-up.
1.4. Possible limitations of this study
The main limitations of this study are that it is a single center study, recruitment
difficulty, and decreasing number of participants during follow-up.
