Preventive effect of Goshajinkigan against CIPN with paclitaxel: an open-label, randomized, phase II study

Phase 2

Recruiting

• Conditions: Malignant tumor; Malignant tumor, Paclitaxel, CIPN; Malignant tumor, Paclitaxel, CIP

• Registration Number: JPRN-jRCTs061210047
• Lead Sponsor: Makimoto Go

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-11-02
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 66

Inclusion Criteria

1) Patients who were pathologically diagnosed with malignant tumor and scheduled to receive at least 4 courses of chemotherapy including Carboplatin and Paclitaxel (Paclitaxel 150 mg/m2 or more every 3-4 weeks).
- Any number of treatment lines can be used.
- Chemotherapy regimens that include angiogenesis inhibitors such as bevacizumab and immune checkpoint inhibitors such as atezolizumab, pembrolizumab, and nivolumab are also acceptable.
2) Patients must be at least 20 years old at the time of consent.
3) Performance status should be 0-1 according to ECOG criteria.
4) Patients must be able to maintain the functions of blood, kidney, and liver.
5) The purpose and content of this study have been explained to the patient, and written consent has been obtained from the patient.

Exclusion Criteria

1) Prior treatment with taxane anticancer agents (paclitaxel, albumin-suspended paclitaxel, docetaxel, cabazitaxel, etc.).
2) Prior history of CIPN.
3) Duloxetine, pregabalin, myrogabalin, gabapentin, mecobalamin, Inflamed skin extract of vaccinia virus-inoculated domestic rabbit, tricyclic antidepressants, and Goshajinkigan, including over-the-counter drug.
4) If the patient has obvious peripheral neuropathy such as numbness or dysesthesia (due to orthopedic disease, diabetes, previous treatment, etc.).
5) Patients who have difficulty in taking Goshajinkigan.
6) Pregnant women, those who may be pregnant, and those who are breast-feeding.
7) Other cases that the principal investigator or sub-investigator deems inappropriate.

Study & Design

• Study Type: Interventional
• Study Design: Not specified