The prophylactic effect of Goshajinkigan for CIPN

JRCT ID: jRCTs021180041

Registered date:26/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Primary mullerian cancer and uterine endometrial cancer
• Date of first enrollment: 01/04/2016
• Target sample size: 90
• Study type: Interventional

Intervention(s)

Group A; Goshajinkigan is given orally 3 times a day from after CIPN episode. It was treated till 1 month after the completion of chemotherapy (TC).
Group B; Goshajinkigan is given orally 3 times a day from before 1 week of chemotherapy (TC).It was treated till 1 month after the completion of chemotherapy (TC).

Outcome(s)

• Primary Outcome: Efficacy and Safety

Secondary Outcome

The completion ratio of chemotherapy (TC regimen)
The dose reduction rate of paclitaxel due to CIPN

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 79age old
• Gender: Female

Include criteria

1) Patients with a histological diagnosis of ovarian cancer, carcinoma of fallopian tube, primary peritoneal cancer and uterine endometrial cancer.
2) Patients who will be treated by paclitaxel and carboplatin regimen (TC) for 6 cycles as first-line chemotheray.
3) ECOG Performance Status is 0-2.
4) Patients who do not have severe liver, renal and bone marrow dysfunction.
5) Patients who have signed informed consent.
6) Age is from 20 to 79 years old.

Exclude criteria

1) Patients who already treated by Goshajinkigan.
2) Patients who have severe peripheral neuropathy.
3) Patients who have diabetic peripheral neuropathy.
4) Patients with pregnant or lactating.
5) Patients who are not eligible by doctors.

Related Information

• Primary Sponsor: Yokoyama Yoshihito