To Study the Individual Variants of Chemotherapy-Induced Neurotoxicity

NCT02481336 | Active Not Recruiting DMC

• 1 other identifier: A-ER-103-395
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Neurotoxicity Syndromes

Keywords

Chemotherapy; Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Adverse events occurring after chemotherapy based on genomic profiling

  up to 2 years after chemotherapy

Secondary Outcomes (7)

• Changes in quality-of-life measured by EORTC CIPN20

  up to 2 years after chemotherapy

• Changes in quality-of-life measured by EQ-5D-3L

  up to 2 years after chemotherapy

• Change from Baseline in nerve conduction velocity (NCV)

  up to 2 years after chemotherapy

• Change from Baseline in quantitative sensory test (QST)

  up to 2 years after chemotherapy

• Change from Baseline in nerve excitability test (NET)

  up to 2 years after chemotherapy

Study Arms (1)

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

Other: Questionnaires; Procedure: Peripheral nervous system examination; Genetic: Whole Genome Sequence

Interventions

Questionnaires OTHER

EORTC CIPN20 and EQ-5D-3L

Cancer patients receiving chemotherapy

Peripheral nervous system examination PROCEDURE

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

Cancer patients receiving chemotherapy

Whole Genome Sequence GENETIC

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

Cancer patients receiving chemotherapy

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Total 300 cancer patients will be enrolled in National Cheng Kung University Hospital from March, 2015 to March, 2017. The subjects are stage I-IV ovarian cancer patients receiving chemotherapy Paclitaxel/Carboplatin, stage II-IV endometrial cancer patients receiving chemotherapy Paclitaxel/Carboplatin, stage III \& high risk stage II colorectal cancer patients receiving chemotherapy with mFOLFOX.

You may qualify if:

• Histologically confirmed epithelial ovarian cancer, endometrial cancer or adenocarcinoma of colon or rectum
• Pathological stage I\~IV for ovarian cancer, stage II\~IV endometrial cancer or stage III \& high risk stage II for colorectal cancer
• Scheduled to receive adjuvant Paclitaxel/Carboplatin for ovarian or endometrial cancer, or mFOLFOX6 for colorectal cancer
• Age ≥ 20 years old
• ECOG Performance status 0-1
• 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).
• Negative pregnancy test for women of childbearing potential only
• Patient willing to provide blood sample for research purposes
• Written informed consent

You may not qualify if:

• Prior treatment with neurotoxic chemotherapy, such as oxaliplatin, cisplatin, carboplatin, taxanes or vinca alkaloids
• Receiving chemotherapy within 6 months
• History of allergy to 5-FU or LV
• Pre-existing peripheral neuropathy of any grade
• A family history of a genetic or familial neuropathy
• Active uncontrolled infection
• 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)
• Poor compliance

Sponsors & Collaborators

• National Cheng-Kung University Hospital: lead

Study Sites (1)

National Cheng Kung University Hospital

Tainan, 704, Taiwan

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood Sample Collection with DNA

MeSH Terms

Conditions

Neurotoxicity Syndromes; Peripheral Nervous System Diseases

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Nervous System Diseases; Poisoning; Chemically-Induced Disorders; Neuromuscular Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Meng-Ru Shen, PHD

  National Cheng Kung University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2015
• First Posted: June 25, 2015
• Study Start: March 1, 2015
• Primary Completion (Estimated): December 31, 2029
• Study Completion (Estimated): December 31, 2029
• Last Updated: April 14, 2026

Record last verified: 2026-04

Locations

TW (1)