Phase I study of the preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity

Phase I study of the preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity - The preventive effect of Kampo medicine on oxaliplatin-induced peripheral neurotoxicity

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000016085

Enrollment

Registered

2014-12-29

Start date

2014-12-29

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

colorectal cancer

Interventions

During XELOX regimen, Kampo medicine is administered as follows: Level 1(TJ-18 7.5g, TJ-3023 0g), Level 2(TJ-18 7.5g, TJ-3023 1.5g), Level 3(TJ-18 7.5g, TJ-3023 3.0g)

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1.histopathological colorectal cancer 2.stage II or III 3.adjuvant chemotherapy using oxaliplatin 4. more than 20 yeras old 5. ECOG Performance Status 0-1 6.no organ failure 7.no chemotherapy 8.informed consent

Exclusion criteria

Exclusion criteria: 1.having resistance for using Kampo 2. chemotherapy using oxaliplatin has been performed 3.having double cancer 4.having serious sensory disturbance 5.having serious drug hypersensitivity 6. having serious infection 7. having serious psycho-neurologic disease 8.having serious complication as follows: uncontrorable diabetes mellitus, uncontrorable hypertension, interstitial pneumonia or pulmonary fibrosis, ileus, and serious heart disease 9. inappropriate judgment for study by clinical investigator

Design outcomes

Primary

Measure	Time frame
Decision of DLT, MTD, RD of Kampo medicine (TJ-3023, TJ-18)	—

Secondary

Measure	Time frame
Decision of RDI of oxaliplatin, Examination for oxaliplatin-induced peripheral neurotoxicity (neurosensory test, QOL)	—

Countries

Japan

Contacts

Public ContactTsukasa Hotta

Wakayama Medical University, School of Medicine Second Department of Surgery

hotta@wakayama-med.ac.jp073-441-0613

Outcome results

None listed

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