Breast Cancer
Conditions
Keywords
breast cancer, chemotherapy, peripherally inserted central catheter, implantable device, randomized controlled trial, iterative placement, Catheterization, Central Venous
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.
Interventions
PROCEDUREIterative PICC placement
Intervention is the catheterisation strategy (not the device)
PROCEDURELong term PAC placement
Intervention is the catheterisation strategy (not the device)
Sponsors
Ministry of Health, France
C. R. Bard
Centre Leon Berard
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
France
Outcome results
None listed