Central Catheters Used for Chemotherapy in Women With Breast Cancer
NCT ID: NCT04324346
Last Updated: 2021-03-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
250 participants
INTERVENTIONAL
2016-04-01
2021-02-01
Brief Summary
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Detailed Description
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Bacterial cultures will be taken at removal of PICC/SVAP. The used PICC/SVAP will be transported to the Royal Institute of Technology (KTH) and subjected to material analyses. Comparison with reference materials from the in-vitro study and with new reference catheters will be performed. Patient assessments with questionnaire concerning HRQL, illness perception, body imaging, life style and sleep disturbance will be collected at baseline and at the last chemotherapy session. Interviews with the patients about life situations will be conducted half through the chemotherapy treatment period.In- and out-patients costs, i.e. medication, materials, costs related to the care of the PICC/SVAP, costs for complications, additional costs for the patients regarding the treatment, etc., will be monitored and registered. In- and out-patient costs will also be monitored. Data from medical records concerning treatments for complications will also be taken into consideration.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
BASIC_SCIENCE
NONE
Study Groups
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PICC-Line
Women allocated to PICC-line when receiving chemotherapy
FEC75 (or EC90) x 6
Type of Chemotherapy
FEC100 + Taxotere (EC90 + Taxotere) 3+3
Type of Chemotherapy
Paclitaxel
Type of Chemotherapy
Subcutaneous Venous Access Port (SVAP)
Women allocated to SVAP when receiving chemotherapy
FEC75 (or EC90) x 6
Type of Chemotherapy
FEC100 + Taxotere (EC90 + Taxotere) 3+3
Type of Chemotherapy
Paclitaxel
Type of Chemotherapy
Interventions
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FEC75 (or EC90) x 6
Type of Chemotherapy
FEC100 + Taxotere (EC90 + Taxotere) 3+3
Type of Chemotherapy
Paclitaxel
Type of Chemotherapy
Eligibility Criteria
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Inclusion Criteria
* speak Swedish
Exclusion Criteria
* and/or inability to understand Swedish,
* recurrent breast cancer
18 Years
80 Years
FEMALE
No
Sponsors
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Karolinska Institutet
OTHER
KTH Royal Institute of Technology
OTHER
Karolinska University Hospital
OTHER
Stockholm South General Hospital
OTHER
Norwegian University of Science and Technology
OTHER
Swedish Red Cross University College
OTHER
Responsible Party
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Gunilla Bjorling
Professor
Principal Investigators
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Gunilla Björling, PhD
Role: STUDY_CHAIR
The Swedish Red Cross University College
Locations
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Onkologiska kliniken, Karolinska University Hospital, Danderyd Hospital
Stockholm, , Sweden
Countries
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Other Identifiers
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RKH2014.1
Identifier Type: -
Identifier Source: org_study_id
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