To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

NCT ID: NCT02481336

Last Updated: 2022-10-04

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-03-31
• Study Completion Date: 2025-12-31

Brief Summary

To study the risk prediction of chemotherapy-induced peripheral neuropathy (CIPN) by the clinical bioinformatics and genomic profile.

Detailed Description

This is a prospective, observational, cohort study, monitoring the chemotherapy-induced peripheral neurotoxicity by traditional clinical scales, neurological examinations, and semi-quantitative assessments. Moreover, all the genetic changes will be analyzed by next generation sequencing and we will try to identify relevant variants in individuals who suffer from chemotherapy-induced neurotoxicity.

Conditions

Neurotoxicity Syndromes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cancer patients receiving chemotherapy

Stage I-IV ovarian cancer receiving chemotherapy Paclitaxel/Carboplatin

Stage II-IV endometrial cancer receiving chemotherapy Paclitaxel/Carboplatin

Stage III & high risk stage II colorectal cancer receiving chemotherapy with mFOLFOX

1. Questionnaires

2. Peripheral nervous system examination

3. Whole Genome Sequence

Questionnaires

Intervention Type: OTHER

EORTC CIPN20 and EQ-5D-3L

Peripheral nervous system examination

Intervention Type: PROCEDURE

nerve conduction velocity (NCV), quantitative sensory test (QST), and nerve excitability test (NET)

Whole Genome Sequence

Intervention Type: GENETIC

Genetic Test : 10 mL blood will be collected in Blood Sample Collection

Interventions

Questionnaires

EORTC CIPN20 and EQ-5D-3L

Intervention Type: OTHER

Peripheral nervous system examination

nerve conduction velocity (NCV), quantitative sensory test (QST), and nerve excitability test (NET)

Intervention Type: PROCEDURE

Whole Genome Sequence

Genetic Test : 10 mL blood will be collected in Blood Sample Collection

Intervention Type: GENETIC

Eligibility Criteria

Inclusion Criteria

1. Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum

2. Pathological stage I~IV for ovarian cancer, stage II~IV endometrial cancer or stage III & high risk stage II for colorectal cancer

3. Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer

4. Age ≥ 20 years old

5. ECOG Performance status 0-1

6. Adequate organ function

Bone marrow:

Absolute neutrophil count (ANC) ≥ 1.5 x 109/L WBC ≥ 3.0 x 109/L Platelet count ≥ 100 x 109/L Hemoglobin ≥ 9 g/dL

Hepatic:

Total bilirubin level ≤ 1.0 x UNL AST and ALT ≤ 3.0 x UNL

Renal:

Creatinine level ≤ 1.5 mg/dL in men, ≤1.4 mg/dL in women; or Estimated CCr ≥ 60 mL/min (CCr is estimated by Cockcroft-Gault formula, as appendix III).

7. Negative pregnancy test for women of childbearing potential only

8. Patient willing to provide blood sample for research purposes

9. Written informed consent

Exclusion Criteria

1. Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids

2. Receiving chemotherapy within 6 months

3. History of allergy to 5-FU or LV

4. Pre-existing peripheral neuropathy of any grade

5. A family history of a genetic or familial neuropathy

6. Active uncontrolled infection

7. Significant medical diseases, such as unstable angina, acute or recent myocardial infarction (<6 months before enrollment), COPD with frequent exacerbation, uncontrolled hypertension, ore cent CVA (<6 months before enrollment)

8. Poor compliance

• Minimum Eligible Age: 20 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cheng-Kung University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Meng-Ru Shen, PHD

Role: STUDY_CHAIR

National Cheng Kung University

Locations

National Cheng Kung University Hospital

Tainan City, , Taiwan

Countries

Taiwan

Other Identifiers

A-ER-103-395

Identifier Type: -

Identifier Source: org_study_id