Iterative PICC Placement Versus Long Term Device (PICC One Day)

A Randomized, Multicentre, Comparative Phase III Study of Catheter-related Complications of an Iterative PICC Placement vs a Long-term PAC in Patients With Breast Cancer

Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly medical devices used for the administration of chemotherapy.

Placement of these devices via central venous access is sometimes responsible for complications.

The incidence of these complications is correlated with the device holding time.

A strategy of iterative PICC placement could significantly reduce these complications.

Study Overview

• Status: Withdrawn
• Conditions: Breast Cancer
• Intervention / Treatment: Procedure: Iterative PICC placement; Procedure: Long term PAC placement

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Julien GAUTIER

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Women older than 18 years old;
• Breast cancer diagnosis histologically proven , for any histological subtypes;
• 4 or 6 indication of neoadjuvant or adjuvant chemotherapy; according to hormonal status and HER2 of the tumors, the patient may be treated concomitantly with hormone therapy and / or trastuzumab; Nota Bene: treatment protocol adopted will imperatively be administered in 3-week cycles.
• Central venous access indication;
• Ability to understand and willingness to comply with the study monitoring;
• Affiliated to the French social security system;
• Informed Consent dated and signed, indicating that the patient has been informed of all pertinent aspects of the study before inclusion.

Exclusion Criteria:

• Any contraindication for placement of a central venous catheter ( hemostasis disorders , active infection treated with antibiotics , ...);
• Patient who can't stop anti -vitamin K treatment ( AVK ) ( a relay by Heparin Low Molecular Weight (LMWH) is possible);
• History of central access, regardless of the indication;
• Any active disease other than cancer pathology , requiring repeated administration of intravenous therapy ;
• Patient deprived of liberty;
• Not monitoring for social, geographical, psychological or family reason.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Iterative PICC placement; New PICC placement at each chemotherapy cycle (removed after treatment administration)	Procedure: Iterative PICC placement; Intervention is the catheterisation strategy (not the device)
Active Comparator: Long term implantable device; Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study	Procedure: Long term PAC placement; Intervention is the catheterisation strategy (not the device)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compare complication rate for iterative placement (PICC) versus long term placement (PAC).	Complication rate will be defined by the proportion of patients with at least one of the following complications from the date of randomization to the end of the study: pneumothorax , hemothorax ,veinous thrombosis, migration or expulsion of the device, fissure or rupture of the catheter, catheter obstruction, extravasation.	6 months after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Success rate for each strategy	Success rate will be determined with the proportion of patients in whom the allocation strategy was conducted until the end of the last cycle of chemotherapy	6 months after randomization
Description of failure causes for each strategy	Causes of failures will be described	6 months after randomization
Level of pain for each strategy	Level of pain will be assessed with the verbal scale rated from 0 to 10	At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1
Quality of Life in both arms	Quality of Life will be assessed with the EQ-5D questionnaire	At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Collaborators: Ministry of Health, France; C. R. Bard

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2018
• Primary Completion (Actual): January 10, 2018
• Study Completion (Actual): January 10, 2018

Study Registration Dates

• First Submitted: May 19, 2016
• First Submitted That Met QC Criteria: May 24, 2016
• First Posted (Estimate): May 27, 2016

Study Record Updates

• Last Update Posted (Actual): February 5, 2018
• Last Update Submitted That Met QC Criteria: February 2, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: breast cancer; randomized controlled trial; chemotherapy; peripherally inserted central catheter; implantable device; Catheterization, Central Venous; iterative placement
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: PICC One Day 01 (ET15-123); 2015-A01822-47 (Other Identifier: ID-RCB number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No