Loading clinical trials...
Loading clinical trials...
Phase II Randomised Study Comparing the Tolerance of PICC Line (Peripherally Inserted Central Catheter) and Implanted Port for Adjuvant Chemotherapy in HER2-negative Early Breast Cancer
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.
Age
18 - No limit years
Sex
FEMALE
Healthy Volunteers
No
Centre Henri Becquerel
Rouen, France
Start Date
April 1, 2014
Primary Completion Date
December 1, 2018
Completion Date
March 1, 2019
Last Updated
July 24, 2018
256
ESTIMATED participants
implanted port for chemo administration (X-port isp)
DEVICE
Use of a PICC line for chemo administration (PowerPICC SOLO²)
DEVICE
Lead Sponsor
Centre Henri Becquerel
NCT07386444
NCT05417867
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and Conditions