Central Catheters Used for Chemotherapy in Women With Breast Cancer

NCT04324346 | Completed DMC

• 1 other identifier: RKH2014.1
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Catheter Related Complications

Keywords

picc-line; central venous access port; catheter related complications; Infections; thrombosis; Material degradation; Health economic costs; Bio-material; Health related quality of life

Outcome Measures

Primary Outcomes (1)

• Complications

  all complications during the chemotherapy treatment period are registered

  Through study completion up to 18 weeks

Secondary Outcomes (7)

• Questionnaire EQ-5D

  At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)

• Questionnaire EORT-QLQ 30

  At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)

• Questionnaire EORT-QLQ BR32

  At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)

• Questionnaire Insomnia Symptom Score

  At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)

• Body Esteem Scale (BES)

  At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)

Other Outcomes (5)

• Morphological material degradation

  After study completion up to 18 weeks

• Health Economy related to HRQL

  At baseline, 9 weeks and at study completion 18 weeks (3 measurements)

• Health Economy related to PICC and SVAP

  Retrospective data assessment after study completion 18 weeks

Study Arms (2)

PICC-Line

EXPERIMENTAL

Women allocated to PICC-line when receiving chemotherapy

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

Subcutaneous Venous Access Port (SVAP)

EXPERIMENTAL

Women allocated to SVAP when receiving chemotherapy

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

Interventions

FEC75 (or EC90) x 6 DRUG

Type of Chemotherapy

PICC-Line; Subcutaneous Venous Access Port (SVAP)

FEC100 + Taxotere (EC90 + Taxotere) 3+3 DRUG

Type of Chemotherapy

PICC-Line; Subcutaneous Venous Access Port (SVAP)

Paclitaxel DRUG

Type of Chemotherapy

PICC-Line; Subcutaneous Venous Access Port (SVAP)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• adjuvant or neo adjuvant chemotherapy,
• speak Swedish

You may not qualify if:

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

Sponsors & Collaborators

• Swedish Red Cross University College: lead
• Karolinska Institutet: collaborator
• KTH Royal Institute of Technology: collaborator
• Karolinska University Hospital: collaborator
• Stockholm South General Hospital: collaborator
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

Onkologiska kliniken, Karolinska University Hospital, Danderyd Hospital

Stockholm, 18288, Sweden

Location

MeSH Terms

Conditions

Infections; Thrombosis

Interventions

Docetaxel; fluorescein isothiocyanate-keyhole limpet hemocyanin; Paclitaxel

Condition Hierarchy (Ancestors)

Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Study Officials

• Gunilla Björling, PhD

  The Swedish Red Cross University College

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 4, 2018
• First Posted: March 27, 2020
• Study Start: April 1, 2016
• Primary Completion: February 1, 2021
• Study Completion: February 1, 2021
• Last Updated: March 18, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)