Iterative PICC Placement Versus Long Term Device
- Conditions
- Breast Cancer
- Interventions
- Procedure: Iterative PICC placementProcedure: Long term PAC placement
- Registration Number
- NCT02784730
- Lead Sponsor
- Centre Leon Berard
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- Female
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Iterative PICC placement Iterative PICC placement New PICC placement at each chemotherapy cycle (removed after treatment administration) Long term implantable device Long term PAC placement Port-a-cath inserted prio first chemotherapy cycle and maintained throughout the study
- Primary Outcome Measures
Name Time Method Compare complication rate for iterative placement (PICC) versus long term placement (PAC). 6 months after randomization 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.
- Secondary Outcome Measures
Name Time Method Success rate for each strategy 6 months after randomization 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
Description of failure causes for each strategy 6 months after randomization Causes of failures will be described
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 Quality of Life will be assessed with the EQ-5D questionnaire
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 Level of pain will be assessed with the verbal scale rated from 0 to 10
Trial Locations
- Locations (1)
Julien GAUTIER
🇫🇷Lyon, France