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

Léon Bérard Center

Status and phase

Withdrawn

Phase 3

Conditions

Breast Cancer

Treatments

Procedure: Iterative PICC placement

Procedure: Long term PAC placement

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT02784730

PICC One Day 01 (ET15-123)

2015-A01822-47 (Other Identifier)

Details and patient eligibility

About

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.

Sex

Female

Ages

18+ years old

Volunteers

No 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.