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Exploratory study of genetic polymorphisms associated with onset and severity of chemotherapy-induced peripheral neuropathy by nanoparticle albumin-bound paclitaxel

Exploratory study of genetic polymorphisms associated with onset and severity of chemotherapy-induced peripheral neuropathy by nanoparticle albumin-bound paclitaxel - Exploratory study of genetic polymorphisms associated with onset and severity of chemotherapy-induced peripheral neuropathy by nanoparticle albumin-bound paclitaxel

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
JPRN
Registry ID
JPRN-UMIN000054887
Enrollment
70
Registered
2024-07-05
Start date
2023-03-01
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

Pancreatic cancer, gastric cancer, non-small cell lung cancer, or breast cancer

Interventions

None listed

Sponsors

Showa University
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1) Patient who are diagnosed as pancreatic cancer, gastric cancer, non-small cell lung cancer, or breast cancer, and planed chemotherapy with nanoparticle albumin-bound paclitaxel (nabPTX) 2) More than fourteen days are passed from last chemotherapy administration in patient who were previously treated 3) Patient who is older than 20 years old at the starting nabPTX 4) Patient with Eastern Cooperative Oncology Group Performance status 0 to 2 5) Patient whose life expectancy is more than 3 months 6) Patient who do not have severe organ disorder and applicable to following criteria; Neutrophil count is more than 1,500/mm3, Platelet count is more than 75,000/mm3, Hemoglobin concentration is more than 9.0g/dL, Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) are twice of upper limit of normal or less; if patient involves liver metastasis, AST and ALT are allowed until 5 times of upper limit of normal or less, Serum creatinine value is 1.5mg/dL or less 7) Patient who provided written informed consent to participate in the study

Exclusion criteria

Exclusion criteria: 1) Patient with interstitial pneumonia or lung fibrosis 2) Patient with serious infection 3) Patient with sensory neuropathy; however, patient who was previously received chemotherapy is allowed to participate in the study if chemotherapy-induced peripheral neuropathy has been recovered grade 1 on Common Terminology Criteria for Adverse Event or less 4) Patient who previously received paclitaxel or nabPTX 5) Patient who suffered from unstable angina or acute myocardial infarction within 3 months 6) Patient with serious disease, i.e. uncontrollable diabetes, liver cirrhosis, etc 7) Patient with active synchronous cancer 8) Patient with active viral hepatitis; however, patient is allowed to participate regardless serological positive for hepatitis B antigen in the study if HBV-DNA level is less than measuring sensitivity 9) Patient who is unsuitable to participate in the study due to mental or neurological disorder 10) Woman with pregnant, lactating women or who wish to pregnant, or man who wish to have children 11) Patient with serious allergy to medicine 12) Patient with unsuitable condition to participate in the study due to any reason by physician's judgement

Design outcomes

Primary

MeasureTime frame
Association between interpatient variability of time to onset of chemotherapy-induced peripheral neuropathy from starting nanoparticle albumin-bound paclitaxel and genetic polymorphisms

Countries

Japan

Contacts

Public ContactHiroo Ishida

Showa University Division of Medical Oncology, Showa University Northern Yokohama Hospital

hishida@med.showa-u.ac.jp045-949-7000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026