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
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Centre Leon Berard
- Locations
- 1
- Primary Endpoint
- Compare complication rate for iterative placement (PICC) versus long term placement (PAC).
- Status
- Withdrawn
- Last Updated
- 8 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Compare complication rate for iterative placement (PICC) versus long term placement (PAC).
Time Frame: 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 Outcomes
- Success rate for each strategy(6 months after randomization)
- Description of failure causes for each strategy(6 months after randomization)
- 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)
- 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)