Study of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- Incidence of neuropathy [18 months]
As measured by cumulative EORTC CIPN-20 scores
Secondary Outcome Measures
- Change in neuropathy [18 months]
As measured by change in EORTC CIPN-20 scores
Eligibility Criteria
Criteria
Inclusion criteria:
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15 years of age or older at the time of informed consent
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Have a confirmed pathologic and/or by tumor marker diagnosis of testicular or extragonadal germ cell cancer.
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Provide written informed consent and assent (if applicable).
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Ability to complete questionnaire(s) in English by themselves or with assistance.
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Willing to provide a 10 mL blood sample for future DNA testing
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Planning to receive at least 3 cycles of cisplatin (20 mg/m2/d for 5 days) based chemotherapy.
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Must agree to continued clinical follow-up at the study cancer center.
Exclusion criteria:
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Diagnosis (current or previous) of peripheral neuropathy (from diabetes or other causes).
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Previous exposure to neurotoxic chemotherapy drugs including taxanes, platinum agents, vinca alkaloids, or epothilones.
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Salvage chemotherapy treatment or bone marrow transplant. Salvage chemotherapy is defined as any treatment after relapse of the disease following initial chemotherapy treatment.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Indiana University Health Hospital | Indianapolis | Indiana | United States | 46202 |
| 2 | Indiana University Health Melvin and Bren Simon Cancer Center | Indianapolis | Indiana | United States | 46202 |
| 3 | Mayo Clinic Department of Medical Oncology | Rochester | Minnesota | United States | 55905 |
Sponsors and Collaborators
- Costantine Albany
- Mayo Clinic
Investigators
- Principal Investigator: Costantine Albany, MD, Indiana University School of Medicine, Indiana University Simon Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IUSCC-0502
- 1412960547