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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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.

Detailed Summary:

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.


Sponsor: Costantine Albany

Current Primary Outcome: Incidence of neuropathy [ Time Frame: 18 months ]

As measured by cumulative EORTC CIPN-20 scores


Original Primary Outcome: Same as current

Current Secondary Outcome: Change in neuropathy [ Time Frame: 18 months ]

As measured by change in EORTC CIPN-20 scores


Original Secondary Outcome: Same as current

Information By: Indiana University

Dates:
Date Received: February 5, 2016
Date Started: July 1, 2015
Date Completion: December 31, 2019
Last Updated: January 27, 2017
Last Verified: January 2017