Genetic Variants and Chemotherapy-induced Abnormal Thermal Sensation

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03252834

Enrollment

Registered

2017-08-17

Start date

2017-07-01

Completion date

2020-12-11

Last updated

2025-07-14

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

Conditions

Chemotherapy-induced Abnormal Thermal Sensation

Brief 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.

Interventions

DIAGNOSTIC_TESTGenetic 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.

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

Inclusion criteria

* Age ≥ 20 years old * Pathological stage I\ IV for ovarian cancer, stage II\ IV for endometrial cancer, or stage III for colorectal cancer. * Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer. * Patient willing to provide blood sample for research purposes. * Ability of the patient to provide informed consent.

Exclusion criteria

* Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids. * Receiving chemotherapy within 6 months. * A family history of a genetic or familial neuropathy * Poor compliance

Design outcomes

Primary

Measure	Time frame	Description
The change of thermal pain threshold	before chemotherapy & 3, 6, and 9 months after chemotherapy	The threshold of detecting heat-induced pain

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026