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Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in case of high risk of recurrence (large tumors, node involvement, high grade…). Due to its toxicity toward veins, chemotherapy must be administered through a central venous device. Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port is subcutaneous and lets patients lead a normal life, but its implant and explant require a cutaneous incision with possible complications (bleeding, pain, infection). For both venous devices, complications such as thrombosis or infection may happen. Published data comparing the two devices are heterogeneous and do not often distinguish patients treated for different diseases at various stages. Empirically in daily practice, for long term use (>6 months) a port is usually preferred, whereas for short-term treatments (<6 weeks) a PICC line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to the other for these patients.
The aim of this study is to prospectively compare the patients' satisfaction and tolerance of each of the two devices.
The intravenous device will be randomly attributed. The adjuvant chemotherapy regimen will be selected according the standards of the center ( 6 cycles of FEC100 or 3 cycles of FEC100 then 3 cycles of Taxotere (docetaxel). The patient will be followed as per center's standards and visits (prior, during and after every drug administration, then monthly for six months). All Adverse Events will be reported.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PICC line | Experimental | Use of a PICC line for chemo administration (PowerPICC SOLO²) |
|
| Implanted Port | Active Comparator | Use of an implanted port for chemo administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| implanted port for chemo administration (X-port isp) | Device |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Probability of occurrence of a significant adverse event related to the central venous device | To define between the two device (PICC line and implanted port) which one provides the less probability of occurrence of a significant adverse event related to the device (SAERD), from the insertion to the first consultation of survey (36-38 weeks after implantation of the device which is also 5 months after its ablation). | 37 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Patients' satisfaction for the use of their central venous device | Evaluation of the patients' satisfaction assessed by the QLQ C30, and by a 19 questions home-made questionnaire dedicated to the use of central veinous devices | 1 year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florian Clatot, MD | Centre Henri Becquerel | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Henri Becquerel | Rouen | 76038 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26342484 | Derived | Lefebvre L, Noyon E, Georgescu D, Proust V, Alexandru C, Leheurteur M, Thery JC, Savary L, Rigal O, Di Fiore F, Veyret C, Clatot F. Port catheter versus peripherally inserted central catheter for postoperative chemotherapy in early breast cancer: a retrospective analysis of 448 patients. Support Care Cancer. 2016 Mar;24(3):1397-403. doi: 10.1007/s00520-015-2901-8. Epub 2015 Sep 5. |
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| Use of a PICC line for chemo administration (PowerPICC SOLO²) | Device | The description of the device could found on the published marketing authorisation |
|
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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