he Investigator Initiated Trials (IIT) for effectiveness and safety of the new developed, cyclic temperature stimulating equipment for chemotherapy-induced peripheral neuropathy

Not Applicable

Recruiting

• Conditions: Diseases of the nervous system

• Registration Number: KCT0004047
• Lead Sponsor: Chonbuk National University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 June 2019

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 15

Inclusion Criteria

1) Patients diagnosed with gastric cancer, lung cancer, colorectal cancer or multiple myeloma and patients aged 19 years or older who received neurotoxic chemotherapy such as oxaliplatin, paclitaxel, docetaxel, thalidomide and bortezomib
2) NCI-CTCAE (National Cancer Institute-Common Terminology Criteria for Adverse Events) patients with grade I or greater peripheral neuropathy
3) A person who has agreed in full to understand and understand the details of this study and then decide to participate voluntarily and observe the precautions.

Exclusion Criteria

1) Those who complain of sensory abnormality due to central nervous system diseases and history such as stroke, cerebral hemorrhage, spinal cord compression syndrome, spinal stenosis
2) Possible peripheral neuropathy due to diabetes or alcohol dependent disease
3) Those taking neurotoxic drugs other than anticancer drugs mentioned in the selection criteria.
4) Diagnosis of peripheral vascular disease
5) Mentally ill patients who have difficulties understanding the questionnaire response and research due to limitations of intelligent retardation or expression
6) Those who refused voluntary consent for the clinical trial
7) Pregnant and lactating women
8) Patients with immunosuppression
9) Patients with a systemic condition
10) Vulnerable Subject in a Vulnerable Environment
1) Those who complain of sensory abnormality due to central nervous system diseases and history such as stroke, cerebral hemorrhage, spinal cord compression syndrome, spinal stenosis
2) Possible peripheral neuropathy due to diabetes or alcohol dependent disease
3) Those taking neurotoxic drugs other than anticancer drugs mentioned in the selection criteria.
4) Diagnosis of peripheral vascular disease
5) Mentally ill patients who have difficulties understanding the questionnaire response and research due to limitations of intelligent retardation or expression
6) Those who refused voluntary consent for the clinical trial
7) Pregnant and lactating women
8) Patients with immunosuppression
9) Patients with a systemic condition
10) Vulnerable Subject in a Vulnerable Environment
11) Drug or alcohol addict

Study & Design

• Study Type: Interventional Study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quantitative analysis of blood flow changes through Labled RBC (Red Blood Cell) imaging

Secondary Outcome Measures

Name	Time	Method
EORTC QLQ-CIPN 20 (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Chemotherapy Induced Peripheral Neuropathy) Questionnaire score change