Iterative PICC Placement Versus Long Term Device

Study Overview
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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.

Official Title
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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

Conditions
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Breast Cancer

Intervention / Treatment
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* Procedure: Iterative PICC placement
* Procedure: Long term PAC placement


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Iterative PICC placement<br>New PICC placement at each chemotherapy cycle (removed after treatment administration) | Procedure: Iterative PICC placement<br>* Intervention is the catheterisation strategy (not the device)<br>|
| Active Comparator: Long term implantable device<br>Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study | Procedure: Long term PAC placement<br>* Intervention is the catheterisation strategy (not the device)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months after randomization | 
| Description of failure causes for each strategy | Causes of failures will be described | 6 months after randomization | 
| Level of pain for each strategy | Level of pain will be assessed with the verbal scale rated from 0 to 10 | 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 | Quality of Life will be assessed with the EQ-5D questionnaire | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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breast cancer, chemotherapy, peripherally inserted central catheter, implantable device, randomized controlled trial, iterative placement, Catheterization, Central Venous