Central Catheters Used for Chemotherapy in Women With Breast Cancer (PICC&PAC)

Swedish Red Cross University College

Status: Completed

Conditions: Catheter Related Complications

Treatments: Drug: FEC75 (or EC90) x 6; Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3; Drug: Paclitaxel

Study type: Interventional

Funder types: Other

Identifiers

NCT04324346

RKH2014.1

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 250 patients

Sex: Female

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• adjuvant or neo adjuvant chemotherapy,
• speak Swedish

Exclusion criteria

• cognitive dysfunction
• and/or inability to understand Swedish,
• recurrent breast cancer

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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250 participants in 2 patient groups

PICC-Line

Experimental group

Description:

Women allocated to PICC-line when receiving chemotherapy

Treatment:

Drug: Paclitaxel

Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3

Drug: FEC75 (or EC90) x 6

Subcutaneous Venous Access Port (SVAP)

Experimental group

Description:

Women allocated to SVAP when receiving chemotherapy

Treatment:

Drug: Paclitaxel

Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3

Drug: FEC75 (or EC90) x 6