Chemotherapy-induced Abnormal Thermal Sensation Clinical Trial
Official title:
To Study the Individual Variants of Chemotherapy-induced Abnormal Thermal Sensation in Cancer Patients
| Verified date | April 2022 |
| Source | National Cheng-Kung University Hospital |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Observational |
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.
| Status | Terminated |
| Enrollment | 12 |
| Est. completion date | December 11, 2020 |
| Est. primary completion date | December 11, 2020 |
| Accepts healthy volunteers | |
| Gender | All |
| Age group | 20 Years and older |
| Eligibility | 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 |
| Country | Name | City | State |
|---|---|---|---|
| Taiwan | National Cheng Kung University Hospital | Tainan |
| Lead Sponsor | Collaborator |
|---|---|
| National Cheng-Kung University Hospital |
Taiwan,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | The change of thermal pain threshold | The threshold of detecting heat-induced pain | before chemotherapy & 3, 6, and 9 months after chemotherapy |