Iterative PICC Placement Versus Long Term Device

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2018-01-10

Study Completion Date

2018-01-10

Brief Summary

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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.

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Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Iterative PICC placement

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

Group Type EXPERIMENTAL

Iterative PICC placement

Intervention Type PROCEDURE

Intervention is the catheterisation strategy (not the device)

Long term implantable device

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

Group Type ACTIVE_COMPARATOR

Long term PAC placement

Intervention Type PROCEDURE

Intervention is the catheterisation strategy (not the device)

Interventions

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Iterative PICC placement

Intervention is the catheterisation strategy (not the device)

Intervention Type PROCEDURE

Long term PAC placement

Intervention is the catheterisation strategy (not the device)

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No