Non-inferiority of Clinical Trials in Comparison With the Length of Totally Implemented Porth-a-Cath Maintenance From 60 Versus 90 Days

NCT05084040 | Unknown Phase 2

• 1 other identifier: 2663-19
• Study Type: interventional
• Target: 410
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Catheter Obstruction

Outcome Measures

Primary Outcomes (1)

• Incidence of catheter obstruction or catheter-related infection

  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%

  1 year

Secondary Outcomes (1)

• Financial toxicity

  1 year

Study Arms (2)

A

NO INTERVENTION

Porth-a-Cath maintenance with 60-day interval

B

EXPERIMENTAL

Porth-a-Cath maintenance with 90-day interval

Other: 90 days interval between catheter maintenance

Interventions

90 days interval between catheter maintenance OTHER

Length of time between catheter maintenances extended from 60 days to 90 days

B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants over 18 years old
• Consent to participate by signing the consent form.
• No intravenous antineoplastic therapy regimen schedule (clinical follow-up).
• To have a functioning, fully implantable catheter with venous return, no resistance during solution infusion, no obstruction or evidence of infection at the time of recruitment.

You may not qualify if:

• \- Use of any type of anticoagulant / antiplatelet drugs.

Sponsors & Collaborators

• AC Camargo Cancer Center: lead

Study Sites (1)

A.C.Camargo Cancer Center

São Paulo, 01509-010, Brazil

RECRUITING

Study Officials

• José Luiz Gasparini-Jr, RN, MSc

  AC Camargo Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jose Luiz Gasparini-Jr, RN, MSc

CONTACT

+5511972873514; jose.gasparini@accamargo.org.br

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2021
• First Posted: October 19, 2021
• Study Start: September 15, 2021
• Primary Completion: December 1, 2021
• Study Completion: January 1, 2023
• Last Updated: October 19, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)