Piolt study of usefulness of analysis of genetic polymorphism of aldehyde dehydrogenase 2 (ALDH2) in safety of paclitaxel for the patients with alcohol intolerance

Not Applicable

• Conditions: Breast cancer, gastric cancer, ovarian cancer, non-small cell lung cancer, head and neck cancer, esophageal cancer

• Registration Number: JPRN-UMIN000007624
• Lead Sponsor: Osaka International Cancer Institute

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-01
• Study Completion: 2016-01-14
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete: follow-up complete
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

1)Pregnancy, the possibility of pregnancy or breast feeding. 2)Patients unable to take paclitaxcel because of significant cardiovascular abnormalities, renal dysfunction, hepatic insufficiency, uncontrolled hypertension, uncontrolled diabetes, bleeding tendency, active interstitial pneumonia ,etc. 3)Febrile patients who are suspected to be infected. 4)Prior treatment with paclitaxcel 5)Patients unable to comply with the protocol, in the opinion of the investigator. 6)Other contraindication to paclitaxcel. (1)severe myelosuppression (2)Known hypersensitivity to paclitaxcel or drugs which contain polyoxyethylene caster oil (e.g. ciclosporin injection). (3) Patient taking disulfiram, cyanamide, carmofur, and procarbazine hydrochloride.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Completion rate of two cycles of weekly paclitaxel

Secondary Outcome Measures

Name	Time	Method
1) Rate of genetic polymorphism of ALDH2, 2) frequency and grade of alcohol associated symptoms after paclitaxel injection, 3)time course of breath alcohol concentration (BAC)