Clinical trial NCT02784730: Iterative PICC Placement Versus Long Term Device
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
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: breast cancer
chemotherapy
peripherally inserted central catheter
implantable device
randomized controlled trial
iterative placement
Catheterization, Central Venous
Lead sponsor: Centre Leon Berard
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
name: C. R. Bard
First posted: 2016-05-27
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.


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.

Primary outcomes:
measure: Compare complication rate for iterative placement (PICC) versus long term placement (PAC).
timeFrame: 6 months after randomization
Secondary outcomes:
measure: Success rate for each strategy
timeFrame: 6 months after randomization
measure: Description of failure causes for each strategy
timeFrame: 6 months after randomization
measure: Level of pain for each strategy
timeFrame: 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
measure: Quality of Life in both arms
timeFrame: 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
Other outcomes:
Locations:
city: Lyon
country: France
facility: Julien GAUTIER
Study officials:
affiliation: Centre Leon Berard
name: Hervé ROSAY, MD
role: PRINCIPAL_INVESTIGATOR
References: