Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel (ALCOOTAX)

April 23, 2015 updated by: Institut Curie

Prospective Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel Infusion

The purpose of this study is to evaluate plasma alcohol concentration in patients receiving Paclitaxel or Docetaxel infusion.

Study Overview

Status

Completed

Conditions

Tumors

Intervention / Treatment

Other: blood sampling

Detailed Description

In this study, there is no experimental treatment, or experimental care.

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

France
- - Paris, France, 75005
    - Institut Curie

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Chemotherapy with docetaxel or paclitaxel on an every 3-week schedule.
Patient with bitherapy are eligible only if the taxane is the first infusion.
All type of tumor.
Age>18 years old.
Signed written informed consent.

Exclusion Criteria:

Patient under 18.
Patient with bitherapy, if docetaxel or paclitaxel is not administered first.
Patient deprived of liberty.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Allocation: N/A
Interventional Model: Single Group Assignment
Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluation of plasma alcohol Time Frame: One year	Measure of the plasma alcohol level before and after a taxane-based therapy (docetaxel or paclitaxel)	One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Institut Curie

Investigators

Principal Investigator: LE TOURNEAU Christophe, MD, Institut Curie

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

February 1, 2012

Study Completion (Actual)

February 1, 2012

Study Registration Dates

First Submitted

October 6, 2011

First Submitted That Met QC Criteria