NCT03252834

Genetic Variants and Chemotherapy-induced Abnormal Thermal Sensation

To Study the Individual Variants of Chemotherapy-induced Abnormal Thermal Sensation in Cancer Patients

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 12 (actual)
• Sponsor: National Cheng-Kung University Hospital · Academic / Other
• Sex: All
• Age: 20 Years
• Healthy volunteers: —

Summary

This is a prospective, single arm, single center study evaluating the use of a 4-gene panel to predict the occurrence of chemotherapy-induced abnormal thermal threshold in endometrial and ovarian cancer patients receiving post-operative chemotherapy with Carboplatin/Paclitaxel, and stage III colorectal cancer patients receiving adjuvant chemotherapy with mFOLFOX6. A total of 100 patients will be enrolled during 2017 July\~ 2019 June. Blood sample will be collected before chemotherapy to analyze the genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1. All patients will receive neurologic examination (Quantitative Sensory Test, QST) and complete the questionnaires for quality of life (EQ5D \& CIPN20). The primary endpoint of this study is to test if the genetic variant of TRPV1, TRPM2, TRPA1, and ORAI1 is a predictive biomarker for the chemotherapy-induced abnormal thermal sensation in cancer patients.

Conditions

• Chemotherapy-induced Abnormal Thermal Sensation

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI	Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI1 will be analyzed. Quantitative Sensory Test, QST, will be used to determined if there is abnormal thermal sensation.

Timeline

• Start date: 2017-07-01
• Primary completion: 2020-12-11
• Completion: 2020-12-11
• First posted: 2017-08-17
• Last updated: 2025-07-14

Locations

1 site across 1 country: Taiwan