Double Phase Clinical Trial to Investigate Prevalence of Neuropathic Pain in Gynecologic Cancer Patients and Efficacy and Safety of Opioids on Pain Management among the Same Population

Double Phase Clinical Trial to Investigate Prevalence of Neuropathic Pain in Gynecologic Cancer Patients and Efficacy and Safety of Opioids on Pain Management among the Same Population - INGyCO study

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-UMIN000013725

Enrollment

Registered

2014-04-15

Start date

2014-04-21

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

Gynecologic malignancies

Interventions

None listed

Eligibility

Sex/Gender

Female

Inclusion criteria

Inclusion criteria: 1. Patients over 20 ages at study entry 2. Patients suffered from neuropathic pain rated over 4 by NRS 3. Patients not administered opioids within 2 weeks before study entry 4. Patients able to communicate and assess his/her own symptoms 5. Patients assessed ECOG-PS as 0-3 6. Patients expecting over 2 months estimate survival after study opening 7. Patients with neuropathic pain due to cancer (nerve compression, invasion to plexus), or mixed pain with cancer treatment related pain(surgery, chemotherapy, radiotherapy) 8. Patients agreed with the written informed consent

Exclusion criteria

Exclusion criteria: 1. Patients hypersensitive to opium alkaloids 2. Patients with serious depressed respiration or serious chronic obstructive lung disease (refer to contraindication) 3. Patients received surgery, chemotherapy or palliative radiotherapy within 2 weeks affected pain assessment, or scheduled these therapies during study period 4. Patients with severely impaired hepatic or renal function 5. Patients pregnant or possibly pregnant 6. Patients with cancer treatment related pain solely 7. Patients judged unsuitable for study subject by responsible physicians due to other clinical reasons

Design outcomes

Primary

Measure	Time frame
1.Patient demographics 2.Pain related 3.QOL related 4.Adverse events 5.Laboratory data 6.Imaging	—

Countries

Japan

Contacts

Public ContactAkiko Tozawa

St. Marianna University School of Medicine Obstatrics and Gynecology

a2ono@marianna-u.ac.jp0449778111

Outcome results