NCT02784730

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.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 19, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 27, 2016

Completed
1.6 years until next milestone

Study Start

First participant enrolled

January 10, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 10, 2018

Completed
Last Updated

February 5, 2018

Status Verified

February 1, 2018

Enrollment Period

Same day

First QC Date

May 19, 2016

Last Update Submit

February 2, 2018

Conditions

Breast Cancer

Keywords

breast cancerchemotherapyperipherally inserted central catheterimplantable devicerandomized controlled trialiterative placementCatheterization, Central Venous

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (4)

  • Success rate for each strategy

    6 months after randomization

  • Description of failure causes for each strategy

    6 months after randomization

  • Level of pain for each strategy

    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

    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

Study Arms (2)

Iterative PICC placement

EXPERIMENTAL

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

Procedure: Iterative PICC placement

Long term implantable device

ACTIVE COMPARATOR

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

Procedure: Long term PAC placement

Interventions

Iterative PICC placementPROCEDURE

Intervention is the catheterisation strategy (not the device)

Iterative PICC placement
Long term PAC placementPROCEDURE

Intervention is the catheterisation strategy (not the device)

Long term implantable device

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women older than 18 years old;
  • Breast cancer diagnosis histologically proven , for any histological subtypes;
  • 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;

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julien GAUTIER

Lyon, 69008, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hervé ROSAY, MD

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2016

First Posted

May 27, 2016

Study Start

January 10, 2018

Primary Completion

January 10, 2018

Study Completion

January 10, 2018

Last Updated

February 5, 2018

Record last verified: 2018-02

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)