Study of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor

Study Overview
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Brief Summary
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This is a prospective observational study investigating the incidence, characteristics of, and change in chronic neuropathy symptoms related to cisplatin using the EORTC CIPN-20 instrument. Approximately 60 patients will be collected for this study. The duration of this study will be up to 18 months for each patient. This study will complement a current R01 funded trial (Platinum Study) which evaluates the genetic predisposition of chronic neuropathy after 12 months of chemotherapy. However, although the platinum study evaluates a similar patient population, it does not evaluate the natural history of platinum induced neuropathy during active treatment and the first 12 months post chemotherapy. This trial will fill this gap and add to the investigators knowledge for both natural history and genetic predisposition of platinum neurotoxicity.

Detailed Description
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Primary Objective: To describe the incidence and characteristics of, and change in, chronic neuropathy symptoms related to cisplatin, using the EORTC CIPN-20 instrument Procedures: The EORTC QLQ-CIPN20 questionnaire will be completed on day one of each cycle of chemotherapy, once every three weeks (+/-7 days) and once every 2 months (+/- 30 days) from the last dose of chemotherapy. Patients will be asked to complete the questionnaire in clinic during their routine visits. As part of this study, a DNA blood sample will be collected and stored with the Indiana Biobank on Day 1 of Cycle 1.

Official Title
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A Study of the Natural History of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor

Conditions
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Testicular Germ Cell Tumor

Intervention / Treatment
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* Other: EORTC QLQ-CIPN20


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: 15 years of age or older at the time of informed consent Have a confirmed pathologic and/or by tumor marker diagnosis of testicular or extragonadal germ cell cancer. Provide written informed consent and assent (if applicable). Ability to complete questionnaire(s) in English by themselves or with assistance. Willing to provide a 10 mL blood sample for future DNA testing Planning to receive at least 3 cycles of cisplatin (20 mg/m2/d for 5 days) based chemotherapy. Must agree to continued clinical follow-up at the study cancer center. Exclusion criteria: Diagnosis (current or previous) of peripheral neuropathy (from diabetes or other causes). Previous exposure to neurotoxic chemotherapy drugs including taxanes, platinum agents, vinca alkaloids, or epothilones. Salvage chemotherapy treatment or bone marrow transplant. Salvage chemotherapy is defined as any treatment after relapse of the disease following initial chemotherapy treatment.

Ages Eligible for Study
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Minimum Age: 15 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: EORTC QLQ-CIPN20|EORTC QLQ-CIPN20 is a 20-item chemotherapy-induced peripheral neuropathy-specific questionnaire which includes three scales assessing sensory (9 items: #31-36, 39, 40, 48), motor (8 items: #37, 38, 41-45, 49), and autonomic (3 items: #46, 47, 50) symptoms and functioning with each item measured on a 1-4 scale (1 - not at all; 4 - very much).|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of neuropathy | As measured by cumulative EORTC CIPN-20 scores | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in neuropathy | As measured by change in EORTC CIPN-20 scores | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cisplatin-based chemotherapy, Chemotherapy-induced peripheral neuropathy