Paclitacel -induced peripheral neuropathy in the patients with gynecological malignancies
Conditions
Interventions
Pregabalin is administered orally at the dose of 25 mg at bedtime. And it is increased sequentially.
Goshajinkigan is administered orally at the dose of 2.5g three times daily.
Sponsors
Nihon University Itabashi Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Patients with gynecological malignancies who have paclitaxel-induced peripheral neuropathy 2)Patients scheduled to receive the chemotherapy by paclitaxel at least 3course 3)The patient by whom the survival for 4 months or more is expected 4)Patients obtained informed consent in a documented form
Exclusion criteria
Exclusion criteria: 1) Patients with severe complications (such as heart failure, renal failure, liver failure, blood disease) 2)Patients with neuropathy due to apparently other causes such as diabetes or cingulum 3)Patients with history of allergy in Pregabalin or Goshajinkigan 4)Patient with the neurological symptoms by brain metastasis or bone metastasis 5)Patients who have been administered Pregabalin or Goshajinkigan previously for peripheral neuropathy 6)Patients for whom completion of this study is deemed inappropriate for any reason
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The level of improvement of peripheral neuropathy is evaluated by Numeric Rating Scale (NRS) after 8 weeks of chemotherapy starts. | — |
Countries
Japan
Contacts
Public ContactKenji Sugita
Nihon University Itabashi Hospital Obstetrics and Gynecology
Outcome results
None listed