Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Carcinoma

Breast Diseases

Skin Diseases

Adjuvants, Anesthesia

Anticonvulsants

Antiemetics

Central Nervous System Depressants

Muscle Relaxants, Central

Psychotropic Drugs

Gastrointestinal Agents

All Drugs and Chemicals

Diazepam

Use of a PICC line for chemo administration (PowerPICC SOLO²)

Use of an implanted port for chemo administration

implanted port for chemo administration (X-port isp)

The description of the device could found on the published marketing authorisation

Florian Clatot, MD

Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in case of high risk of recurrence (large tumors, node involvement, high grade...). Due to its toxicity toward veins, chemotherapy must be administered through a central venous device. Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port is subcutaneous and lets patients lead a normal life, but its implant and explant require a cutaneous incision with possible complications (bleeding, pain, infection). For both venous devices, complications such as thrombosis or infection may happen. Published data comparing the two devices are heterogeneous and do not often distinguish patients treated for different diseases at various stages. Empirically in daily practice, for long term use (\>6 months) a port is usually preferred, whereas for short-term treatments (\<6 weeks) a PICC line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to the other for these patients.

The aim of this study is to prospectively compare the patients' satisfaction and tolerance of each of the two devices.

The intravenous device will be randomly attributed. The adjuvant chemotherapy regimen will be selected according the standards of the center ( 6 cycles of FEC100 or 3 cycles of FEC100 then 3 cycles of Taxotere (docetaxel). The patient will be followed as per center's standards and visits (prior, during and after every drug administration, then monthly for six months). All Adverse Events will be reported.

Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer

Phase II Randomised Study Comparing the Tolerance of PICC Line (Peripherally Inserted Central Catheter) and Implanted Port for Adjuvant Chemotherapy in HER2-negative Early Breast Cancer

To define between the two device (PICC line and implanted port) which one provides the less probability of occurrence of a significant adverse event related to the device (SAERD), from the insertion to the first consultation of survey (36-38 weeks after implantation of the device which is also 5 months after its ablation).

Evaluation of the patients' satisfaction assessed by the QLQ C30, and by a 19 questions home-made questionnaire dedicated to the use of central veinous devices

Centre Henri Becquerel

Infections

Symptoms and General Pathology

Communicable Diseases

Bacteremia

Sepsis

Toxemia

Bacterial Infections

Mycoses

Bacterial Infections and Mycoses

Syndrome

Systemic Inflammatory Response Syndrome

Inflammation

Rajesh V Lalla, DDS, Ph.D

Patients who are preparing to receive chemotherapy are asked to have their teeth cleaned before starting treatment as standard of care. This research study is being done to see if having dental cleaning increases the chances of bacteria from the mouth getting into the blood stream. It is also being done to see if these bacteria can cause blood stream infections in people who have a Central Venous Catheter (CVC),often called a "port" or a "PICC", placed for giving chemotherapy. It is a well-established fact that we introduce bacteria from the mouth into the bloodstream with activities of daily life including chewing, flossing and brushing teeth. This introduction of bacteria into the blood stream may cause bacteria to stick to the central venous catheter and serve as a source of infection when the immune system is weakened by cancer. The purpose of this research study is to see if we can find bacteria from mouth in blood that is drawn through the CVC, during, and after a dental cleaning procedure. This way, we will be able to assess whether or not this is a potential health risk to cancer patients.

Dental Study in Cancer Patients With Central Venous Catheters

Pilot Study on Transient Bacteremia and Blood Stream Infections After Invasive Dental Procedures in Cancer Patients With Central Venous Catheters

Blood cultures drawn before dental cleaning, 20 minutes after starting procedure, 30 minutes after finishing the procedure and at 24 hours after starting the procedure. Records reviewed at one month and six months post procedure for bloodstream or central venous catheter infection.

Rajesh Lalla

Associate Professor, School of Dental Medicine

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer	NCT02095743	Early Stage Bre...	implanted port ... Use of a PICC l...	18 Years -	Centre Henri Becquerel
Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer	NCT02095743	Early Stage Bre...	implanted port ... Use of a PICC l...	18 Years -	Centre Henri Becquerel
Dental Study in Cancer Patients With Central Venous Catheters	NCT00798330	Cancer		18 Years -	UConn Health

Spots Global Cancer Trial Database for picc line

Every month we try and update this database with for picc line cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for picc line

Every month we try and update this database with for picc line cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for picc line cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.