Genetic Variants and Chemotherapy-induced Abnormal Thermal Sensation

Terminated

• Conditions: Chemotherapy-induced Abnormal Thermal Sensation
• Interventions: Diagnostic Test: Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI

• Registration Number: NCT03252834
• Lead Sponsor: National Cheng-Kung University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-07-01
• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-17
• Primary Completion: 2020-12-11
• Study Completion: 2020-12-11
• Status Verified: 2022-04
• Last Update Submitted: 2022-04-07
• Last Update Posted: 2022-04-14

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 12

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with endometrial or ovarian cancer	Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI	-
Patients with colorectal cancer	Genetic variants of TRPV1, TRPM2, TRPA1 and ORAI	-

Primary Outcome Measures

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

Trial Locations

Locations (1)

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan