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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT1070210108

Enrollment

Registered

2022-01-13

Start date

2018-05-22

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

Esophageal cancer, gastric cancer, colorectal cancer, pancreatic cancer Esophageal cancer, gastric cancer, colorectal cancer, pancreatic cancer

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
1) The distinction of the neuropathic disorder type by oxaliplatin, paclitaxel by the examination of nerve conduction and nab paclitaxel and the comparison. 2) 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

Measure	Time frame
End-point before treatment Patients background: Patients initial, sex, the date of birth, clinical record number, anterior chemotherapy history (treatment regimen, total course number, effect of treatment, last administration day), presence or absence of other treatment,Presence, history of previous complications, own objective finding (including the peripheral neuropathy evaluation by DEB-NTC, CTCAEver. 4.0 and PRO-CTCAETM), neurologic physical examination, height, weight, body-surface area, PS An examination: CT or MRI, examination of nerve conduction, examination of vibratory sensation End-point during duration of treatment 1) We measure every two weeks CTCAEver. Peripheral neuropathy evaluation by 4.0 and PRO-CTCAETM 2) We measure every four weeks Examination of nerve conduction using the examination of nerve conduction DPN check These items describe a number in applicable record paper (episode of care record paper) on an expression of grade and grade day.In addition, 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 Neurologic physical examination 3) We perform it 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.	—

Measure

Time frame

End-point before treatment Patients background: Patients initial, sex, the date of birth, clinical record number, anterior chemotherapy history (treatment regimen, total course number, effect of treatment, last administration day), presence or absence of other treatment,Presence, history of previous complications, own objective finding (including the peripheral neuropathy evaluation by DEB-NTC, CTCAEver. 4.0 and PRO-CTCAETM), neurologic physical examination, height, weight, body-surface area, PS An examination: CT or MRI, examination of nerve conduction, examination of vibratory sensation End-point during duration of treatment 1) We measure every two weeks CTCAEver. Peripheral neuropathy evaluation by 4.0 and PRO-CTCAETM 2) We measure every four weeks Examination of nerve conduction using the examination of nerve conduction DPN check These items describe a number in applicable record paper (episode of care record paper) on an expression of grade and grade day.In addition, 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 Neurologic physical examination 3) We perform it 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.

—

Contacts

Public ContactInagaki Takashi

Oita University Hospital

inagakit@oita-u.ac.jp+81-97-586-6275

Outcome results