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

JRCT ID: jRCT1070210108

Registered date:13/01/2022

Basic Information

• Recruitment status: Not Recruiting
• Health condition(s) or Problem(s) studied: Esophageal cancer, gastric cancer, colorectal cancer, pancreatic cancer
• Date of first enrollment: 22/05/2018
• Target sample size: 30
• Study type: Observational

Outcome(s)

Primary Outcome

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 Outcome

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.

Key inclusion & exclusion criteria

• Age minimum: Not applicable
• Age maximum: Not applicable
• Gender: Both

Include 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.

Exclude 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.

Related Information

• Primary Sponsor: Takashi Inagaki