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

JRCT ID: jRCTs061210047

Registered date:02/11/2021

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Malignant tumor
• Date of first enrollment: 27/04/2022
• Target sample size: 66
• Study type: Interventional

Intervention(s)

Enrolled patients will be randomly assigned to two groups.
Group A: Prophylactic group
Starting on the morning of the first day of chemotherapy with carboplatin plus paclitaxel, patients will receive 7.5 g (3 packets) of Goshajinkigan in two to three divided doses daily (before, between, or after meals).
Continue until at least 21 days after (Day 22) the fourth course of chemotherapy including carboplatin plus paclitaxel.

Group B: Non-prophylaxis group (usual care)
No prophylaxis will be given. When Grade 2 or higher peripheral neuropathy develops, consider initiating response therapy (including Goshajinkigan). (If therapeutic intervention for peripheral neuropathy, or reduction, discontinuation, or prolongation of the dosing interval of paclitaxel is required due to peripheral neuropathy, it is considered to be Grade 2 or higher.)

Outcome(s)

• Primary Outcome: Percentage of patients with grade 2 or higher CIPN based on CTCAE ver5.0 by the end of 4 courses of chemotherapy

Secondary Outcome

1) Time from the start of chemotherapy to the onset of CIPN Grade 2
2) Incidence rate and severity of CIPN at the end of each course (assessed by CTCAE Grade and PNQ questionnaire)
3) Relative dose intensity of PTX
4) Adverse events other than peripheral neuropathy
5) Percentage of patients with grade 2 or higher CIPN by the end of 4 courses of chemotherapy (excluding cases who could not receive 4 courses for reasons other than CIPN)
6) Time to treatment failure (TTF)

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Makimoto Go