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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0004047

Enrollment

Registered

2019-06-11

Start date

2017-10-23

Completion date

Unknown

Last updated

2019-06-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : The medical device used in this study is HT-001, which is under development. Repeated temperature therapy consists of a gradual change in the temperature of 15 to 41 degrees with a co

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Quantitative analysis of blood flow changes through Labled RBC (Red Blood Cell) imaging	—

Secondary

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

Countries

Korea, Republic of

Contacts

Public ContactMinjoo Kim

Chonbuk National University

magnet87@naver.com+82-63-259-3137

Outcome results