Iterative PICC Placement Versus Long Term Device

Breast Cancer Clinical Trial

— PICC One Day  

Official title:

A Randomized, Multicentre, Comparative Phase III Study of Catheter-related Complications of an Iterative PICC Placement vs a Long-term PAC in Patients With Breast Cancer

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02784730
• Other study ID #: PICC One Day 01 (ET15-123)
• Secondary ID: 2015-A01822-47
• Status: Withdrawn
• Phase: Phase 3
• First received: May 19, 2016
• Last updated: February 2, 2018
• Start date: January 10, 2018
• Est. completion date: January 10, 2018

Study information

• Verified date: February 2018
• Source: Centre Leon Berard
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Peripherally Inserted Central Catheter (PICC) and port-a-cath (PAC) are the most commonly medical devices used for the administration of chemotherapy.

Placement of these devices via central venous access is sometimes responsible for complications.

The incidence of these complications is correlated with the device holding time.

A strategy of iterative PICC placement could significantly reduce these complications.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 10, 2018
• Est. primary completion date: January 10, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Women older than 18 years old;

• Breast cancer diagnosis histologically proven , for any histological subtypes;

• 4 or 6 indication of neoadjuvant or adjuvant chemotherapy; according to hormonal status and HER2 of the tumors, the patient may be treated concomitantly with hormone therapy and / or trastuzumab; Nota Bene: treatment protocol adopted will imperatively be administered in 3-week cycles.

• Central venous access indication;

• Ability to understand and willingness to comply with the study monitoring;

• Affiliated to the French social security system;

• Informed Consent dated and signed, indicating that the patient has been informed of all pertinent aspects of the study before inclusion.

Exclusion Criteria:

• Any contraindication for placement of a central venous catheter ( hemostasis disorders , active infection treated with antibiotics , ...);

• Patient who can't stop anti -vitamin K treatment ( AVK ) ( a relay by Heparin Low Molecular Weight (LMWH) is possible);

• History of central access, regardless of the indication;

• Any active disease other than cancer pathology , requiring repeated administration of intravenous therapy ;

• Patient deprived of liberty;

• Not monitoring for social, geographical, psychological or family reason.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Iterative PICC placement
Intervention is the catheterisation strategy (not the device)
• Long term PAC placement
Intervention is the catheterisation strategy (not the device)

Locations

Country	Name	City	State
France	Julien GAUTIER	Lyon

Sponsors (3)

Lead Sponsor	Collaborator
Centre Leon Berard	C. R. Bard, Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare complication rate for iterative placement (PICC) versus long term placement (PAC).	Complication rate will be defined by the proportion of patients with at least one of the following complications from the date of randomization to the end of the study: pneumothorax , hemothorax ,veinous thrombosis, migration or expulsion of the device, fissure or rupture of the catheter, catheter obstruction, extravasation.	6 months after randomization
Secondary	Success rate for each strategy	Success rate will be determined with the proportion of patients in whom the allocation strategy was conducted until the end of the last cycle of chemotherapy	6 months after randomization
Secondary	Description of failure causes for each strategy	Causes of failures will be described	6 months after randomization
Secondary	Level of pain for each strategy	Level of pain will be assessed with the verbal scale rated from 0 to 10	At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1
Secondary	Quality of Life in both arms	Quality of Life will be assessed with the EQ-5D questionnaire	At Cycle 1 Day 1, Cycle 2 Day 1, Cycle 3 Day 1, Cycle 4 Day 1, Cycle 5 Day 1, Cycle 6 Day 1