Examination of the rating system of peripheral neuropathy by oxaliplatin, paclitaxel using the nerve conduction survey instrument and nab paclitaxel

Active, not recruiting

• Conditions: Esophageal cancer, gastric cancer, colorectal cancer, pancreatic cancer

• Registration Number: jRCT1070210108
• Lead Sponsor: Takashi Inagaki

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-22
• Study First Submitted: 2022-01-13
• Last Update Posted: 2023-04-11

Recruitment & Eligibility

• Status: Not Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. We have unresectable progress, recurrence digestion ductal carcinoma (esophageal cancer, gastric cancer or colorectal cancer), pancreatic cancer.
2. We plan to receive chemotherapy including oxaliplatin or paclitaxel or nab paclitaxel.
3. There is no peripheral neuropathy before start of therapy subjectively.
4. Performance Status (PS): It is ECOG 2 or less.
5. A major organ function is kept enough.
6. An agreement is obtained in a document from patients about study entry.

Exclusion Criteria

1. We have the brain metastasis with the symptom.
2. We have diabetes mellitus inadequate control.
3. We judge the medical attendant to be inadequate as an object of this study.

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The distinction of the neuropathic disorder type by oxaliplatin, paclitaxel		The distinction of the neuropathic disorder type by oxaliplatin, paclitaxel by the examination of nerve conduction and nab paclitaxel and the comparison.
The predictability of the examination using the examination of nerve conduction DPN check for the neuropathy with the chemotherapy of nerve conduction or the vibratory sensation examination using the tuning fork system and validity		The predictability of the examination using the examination of nerve conduction DPN check for the neuropathy with the chemotherapy of nerve conduction or the vibratory sensation examination using the tuning fork system and validity.

Secondary Outcome Measures

Name	Time	Method
CTCAEver. Peripheral neuropathy evaluation by 4.0 and PRO-CTCAETM	every two weeks	Peripheral neuropathy evaluation by DEB-NTC, CTCAEver. 4.0 and PRO-CTCAETM
Examination of nerve conduction using the examination of nerve conduction DPN check	every four weeks	Examination of nerve conduction using the examination of nerve conduction DPN check. The examination of nerve conduction is desirable before oxaliplatin or paclitaxel or nab paclitaxel administration so that acute neuropathic effect is not included.
Examination of vibratory sensation using the tuning fork meter	every four weeks	Examination of vibratory sensation using the tuning fork meter
Neurologic physical examination	every four weeks	Neurologic physical examination
Brain MRI or CT	depending on the situation	When a headache, convulsions, the reversible posterior leukoencephalopathy syndrome including mental status changes are suspected, we perform brain MRI or CT.