Catheter Related ComplicationsPICC&PACNCT04324346
Central Catheters Used for Chemotherapy in Women With Breast Cancer
A study testing FEC75 (or EC90) x 6, FEC100 + Taxotere (EC90 + Taxotere) 3+3 and Paclitaxel in people with Catheter Related Complications, run by Swedish Red Cross University College at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Catheter Related Complications
- What is being tested?
- FEC75 (or EC90) x 6, FEC100 + Taxotere (EC90 + Taxotere) 3+3 and Paclitaxel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 250 participants
- Where
- 1 siteSweden
- Study dates
- 1 Apr 2016to 1 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- adjuvant or neo adjuvant chemotherapy,
- speak Swedish
Who cannot join
- cognitive dysfunction
- and/or inability to understand Swedish,
- recurrent breast cancer
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Onkologiska kliniken, Karolinska University Hospital, Danderyd Hospital
Stockholm, 18288
About this study
Official title: 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.
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.
Read the detailed 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.
- Conditions
- Catheter Related Complications
- Being tested
- FEC75 (or EC90) x 6, FEC100 + Taxotere (EC90 + Taxotere) 3+3, Paclitaxel
- Keywords
- picc-line, central venous access port, catheter related complications, Infections, thrombosis, Material degradation, Health economic costs, Bio-material, Health related quality of life
- Medical subject headings
- Infections, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FEC75 (or EC90) x 6Drug
Type of Chemotherapy
FEC100 + Taxotere (EC90 + Taxotere) 3+3Drug
Type of Chemotherapy
PaclitaxelDrug
Type of Chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| PICC-Line | Experimental | Women allocated to PICC-line when receiving chemotherapy Receives: 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 Receives: Drug: FEC75 (or EC90) x 6; Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3; Drug: Paclitaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complications
all complications during the chemotherapy treatment period are registered
Measured: Through study completion up to 18 weeks
Secondary outcomes (7)
Questionnaire EQ-5D
Health related quality of life is measured with scores and a scale using EQ-5D.
Measured: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Questionnaire EORT-QLQ 30
To measure Health related quality of life for patients with cancer the questionnaire EORT-QLQ 30 (Scores) is used.
Measured: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Questionnaire EORT-QLQ BR32
The Questionnaire EORT-QLQ BR32 (Scores) is used to measure Health related quality of life for patients with breast cancer
Measured: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Questionnaire Insomnia Symptom Score
To measure Sleep disturbance the questionnaire Insomnia Symptom Score (Scores) is used.
Measured: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Body Esteem Scale (BES)
The participants Body image is measured by Questionnaire: Body Esteem Scale (BES) (Scores)
Measured: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Enriched Social Support Instrument (ESSI)
The participants social support is measured with the questionnaire: Enriched Social Support Instrument (ESSI) (Scores)
Measured: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Brief-Illness Perception Questionnaire (B-IPQ)
Illness Perception is measured with the questionnaire: Brief-Illness Perception Questionnaire (B-IPQ) (scores)
Measured: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2020
- Study start1 Apr 2016
- Primary completion1 Feb 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Catheter Related ComplicationsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 250 participants (actual)
Sponsor and investigators
- Lead sponsor
- Swedish Red Cross University College
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska Institutet, KTH Royal Institute of Technology, Karolinska University Hospital, Stockholm South General Hospital, Norwegian University of Science and Technology
- Responsible party
- Principal investigator, Gunilla Bjorling, Swedish Red Cross University College
- Investigators
- Gunilla Björling, PhD, Study chair, The Swedish Red Cross University College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04324346
- Sponsor's protocol ID
- RKH2014.1
- Acronym
- PICC&PAC
- Status last verified
- Mar 2021
- First submitted
- 4 Sep 2018
- Last updated
- 18 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data will be available 36 months after study completion.
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT04324346
- Acronym / sponsor ID
- PICC&PAC / RKH2014.1
- Conditions
- Catheter Related Complications
- Keywords
- picc-line, central venous access port, catheter related complications, Infections, thrombosis, Material degradation, Health economic costs, Bio-material
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 250 participants (actual)
- Lead sponsor
- Swedish Red Cross University CollegeUniversity, hospital or other
- Collaborators
- Karolinska Institutet, KTH Royal Institute of Technology, Karolinska University Hospital, Stockholm South General Hospital, Norwegian University of Science and Technology
- Study start
- 1 Apr 2016 (actual)
- Primary completion
- 1 Feb 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 27 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICC-Line | Experimental | Drug: FEC75 (or EC90) x 6, Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3, Drug: PaclitaxelWomen allocated to PICC-line when receiving chemotherapy |
| Subcutaneous Venous Access Port (SVAP) | Experimental | Drug: FEC75 (or EC90) x 6, Drug: FEC100 + Taxotere (EC90 + Taxotere) 3+3, Drug: PaclitaxelWomen allocated to SVAP when receiving chemotherapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- adjuvant or neo adjuvant chemotherapy,
- speak Swedish
Key exclusion criteria (3 listed)
- cognitive dysfunction
- and/or inability to understand Swedish,
- recurrent breast cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEC75 (or EC90) x 6Type of Chemotherapy | Drug | PICC-Line, Subcutaneous Venous Access Port (SVAP) |
| FEC100 + Taxotere (EC90 + Taxotere) 3+3Type of Chemotherapy | Drug | PICC-Line, Subcutaneous Venous Access Port (SVAP) |
| PaclitaxelType of Chemotherapy | Drug | PICC-Line, Subcutaneous Venous Access Port (SVAP) |
Primary outcome
Complications
Time frame: Through study completion up to 18 weeks
all complications during the chemotherapy treatment period are registered
7 secondary outcomes
Questionnaire EQ-5D
Time frame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Questionnaire EORT-QLQ 30
Time frame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Questionnaire EORT-QLQ BR32
Time frame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Questionnaire Insomnia Symptom Score
Time frame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Body Esteem Scale (BES)
Time frame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Enriched Social Support Instrument (ESSI)
Time frame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Brief-Illness Perception Questionnaire (B-IPQ)
Time frame: At baseline, at 9 weeks and at end of treatment period 18 weeks (3 measurements)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2021.
- Individual participant dataSharing planned: No. Data will be available 36 months after study completion.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gunilla Björling, PhD study chair
The Swedish Red Cross University College
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEC75 (or EC90) x 6, FEC100 + Taxotere (EC90 + Taxotere) 3+3 and Paclitaxel in people with Catheter Related Complications, run by Swedish Red Cross University College at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complications (time frame: Through study completion up to 18 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.