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NCT01448759 Clinical Trial

Evaluation of Plasma Alcohol Concentration in Patients Receiving Paclitaxel or Docetaxel

Tumors Clinical Trial

— ALCOOTAX  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01448759
Other study ID # IC 2011-03
Secondary ID
Status Completed
Phase N/A
First received October 6, 2011
Last updated April 23, 2015
Start date October 2011
Est. completion date February 2012

Study information
Verified date April 2015
Source Institut Curie
Contact n/a
Is FDA regulated No
Health authority France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
Study type Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 30
Est. completion date February 2012
Est. primary completion date February 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

Intervention

Other:
• blood sampling
Other: Blood sampling 10mL of peripherical blood will be collected specially for the study. It's an additional blood sampling compare to the normal follow up of the patient.

Locations
Country Name City State
France Institut Curie Paris

Sponsors (1)
Lead Sponsor Collaborator
Institut Curie

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary Evaluation of plasma alcohol Measure of the plasma alcohol level before and after a taxane-based therapy (docetaxel or paclitaxel) One year No
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