NCT02677727

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 54 (actual)
• Sponsor: Costantine Albany · Academic / Other
• Sex: Male
• Age: 15 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Testicular Germ Cell Tumor

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2015-07-01
• Primary completion: 2020-06-17
• Completion: 2020-06-17
• First posted: 2016-02-09
• Last updated: 2020-09-22

Locations

3 sites across 1 country: United States