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

Primary Purpose

Breast Cancer

Status
Withdrawn
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Iterative PICC placement
Long term PAC placement
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Breast Cancer focused on measuring breast cancer, chemotherapy, peripherally inserted central catheter, implantable device, randomized controlled trial, iterative placement, Catheterization, Central Venous

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Julien GAUTIER

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Iterative PICC placement

Long term implantable device

Arm Description

New PICC placement at each chemotherapy cycle (removed after treatment administration)

Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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
Description of failure causes for each strategy
Causes of failures will be described
Level of pain for each strategy
Level of pain will be assessed with the verbal scale rated from 0 to 10
Quality of Life in both arms
Quality of Life will be assessed with the EQ-5D questionnaire

Full Information

First Posted
May 19, 2016
Last Updated
February 2, 2018
Sponsor
Centre Leon Berard
Collaborators
Ministry of Health, France, C. R. Bard
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1. Study Identification

Unique Protocol Identification Number
NCT02784730
Brief Title
Iterative PICC Placement Versus Long Term Device
Acronym
PICC One Day
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Changes of the standard adjuvant treatment which does not allow an iterative PICC placement
Study Start Date
January 10, 2018 (Actual)
Primary Completion Date
January 10, 2018 (Actual)
Study Completion Date
January 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard
Collaborators
Ministry of Health, France, C. R. Bard

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, chemotherapy, peripherally inserted central catheter, implantable device, randomized controlled trial, iterative placement, Catheterization, Central Venous

7. Study Design

Primary Purpose
Other
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Iterative PICC placement
Arm Type
Experimental
Arm Description
New PICC placement at each chemotherapy cycle (removed after treatment administration)
Arm Title
Long term implantable device
Arm Type
Active Comparator
Arm Description
Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study
Intervention Type
Procedure
Intervention Name(s)
Iterative PICC placement
Intervention Description
Intervention is the catheterisation strategy (not the device)
Intervention Type
Procedure
Intervention Name(s)
Long term PAC placement
Intervention Description
Intervention is the catheterisation strategy (not the device)
Primary Outcome Measure Information:
Title
Compare complication rate for iterative placement (PICC) versus long term placement (PAC).
Description
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.
Time Frame
6 months after randomization
Secondary Outcome Measure Information:
Title
Success rate for each strategy
Description
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
Time Frame
6 months after randomization
Title
Description of failure causes for each strategy
Description
Causes of failures will be described
Time Frame
6 months after randomization
Title
Level of pain for each strategy
Description
Level of pain will be assessed with the verbal scale rated from 0 to 10
Time Frame
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
Title
Quality of Life in both arms
Description
Quality of Life will be assessed with the EQ-5D questionnaire
Time Frame
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hervé ROSAY, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
Facility Information:
Facility Name
Julien GAUTIER
City
Lyon
ZIP/Postal Code
69008
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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Iterative PICC Placement Versus Long Term Device

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