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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007624

Enrollment

Registered

2012-04-01

Start date

2012-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Patients with ALDH2*1/*1 will be injected paclitaxel for 1 hour, and patients with ALDH2*1/*2 will be injected it for three hours.Frequency and grade of alcohol associated symptoms will be checked aft

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1)ECOG scale: PS0-2 2)Patient with enough feasibility for planned chemotherapy which contains paclitaxcel (hematological, liver, renal, cardiopulmonary function) 3)Patient suspected to have intolerance for alcohol on medical interview, e.g. patient who feel uneasy about taking a glass of beer ( about 180ml) 4)Written informed consent

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Completion rate of two cycles of weekly paclitaxel	—

Secondary

Measure	Time frame
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)	—

Countries

Japan

Contacts

Public ContactToshinari Yagi

Osaka International Cancer Institute Department of Clinical Oncology

yagi-to@mc.pref.osaka.jp06-6945-1181

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026