Trial | NCT04324346  Report issue

Title

Central Catheters Used for Chemotherapy in Women With Breast Cancer
Evaluation of Central Venous Catheters Used for Chemotherapy in Women With Breast Cancer - An Interdisciplinary Randomized Controlled Study of Complications, Material Wear, Staff- and Patient Perspectives, and Health Economy.

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    250
The overall aim of this study is to evaluate two different central venous lines, PICC-lines (PICC) and subcutaneous venous access ports (SVAP) used for chemotherapy in women with breast cancer. The study will compare complications, material wear of the catheters used, patients'- and health care professionals' experiences, and costs. The study will give knowledge about which central venous access that is the most advantageous regarding adjuvant chemotherapy for women with breast cancer in the aspects of safety, quality of care, and quality of life.
N=250 women between 18 and 70 years of age with invasive breast cancer who are allocated to adjuvant or neo adjuvant chemotherapy during 18 weeks at the Department of Oncology at Karolinska University Hospital , Stockholm Sweden are eligible to participate in the present study. Exclusion criteria are cognitive dysfunction and/or inability to understand Swedish. Before participation an informed consent will be collected. The patients will be randomized to receive a PICC or a SVAP. Complications will be registered as well as the treatments.

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.
Study Started
Apr 01
2016
Primary Completion
Feb 01
2021
Study Completion
Feb 01
2021
Last Update
Mar 18
2021

Drug FEC75 (or EC90) x 6 [fluorouracil (efudex), epirubicin (ellence), cyclophosphamide (cytoxan)]

Type of Chemotherapy

Drug FEC100 + Taxotere (EC90 + Taxotere) 3+3 [fluorouracil (efudex), epirubicin (ellence), cyclophosphamide (cytoxan), docetaxel (taxotere)]

Type of Chemotherapy

Drug Paclitaxel

Type of Chemotherapy

PICC-Line Experimental

Women allocated to PICC-line when receiving chemotherapy

Subcutaneous Venous Access Port (SVAP) Experimental

Women allocated to SVAP when receiving chemotherapy

Criteria 

Inclusion Criteria:

adjuvant or neo adjuvant chemotherapy,
speak Swedish

Exclusion Criteria:

cognitive dysfunction
and/or inability to understand Swedish,
recurrent breast cancer
No Results Posted