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

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.

Study Overview

• Status: Completed
• Conditions: Testicular Germ Cell Tumor
• Intervention / Treatment: Other: EORTC QLQ-CIPN20

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 Type: Observational
• Enrollment (Actual): 54

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Melvin and Bren Simon Cancer Center
    • Indianapolis, Indiana, United States, 46202
      • Indiana University Health Hospital
  • Minnesota
    • Rochester, Minnesota, United States, 55905
      • Mayo Clinic Department of Medical Oncology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

• Sampling Method: Non-Probability Sample

Study Population

Patients who are beign treated with cisplatin-based chemotherapy for testicular germ cell tumor

Description

Inclusion criteria:

1. 15 years of age or older at the time of informed consent
2. Have a confirmed pathologic and/or by tumor marker diagnosis of testicular or extragonadal germ cell cancer.
3. Provide written informed consent and assent (if applicable).
4. Ability to complete questionnaire(s) in English by themselves or with assistance.
5. Willing to provide a 10 mL blood sample for future DNA testing
6. Planning to receive at least 3 cycles of cisplatin (20 mg/m2/d for 5 days) based chemotherapy.
7. Must agree to continued clinical follow-up at the study cancer center.

Exclusion criteria:

1. Diagnosis (current or previous) of peripheral neuropathy (from diabetes or other causes).
2. Previous exposure to neurotoxic chemotherapy drugs including taxanes, platinum agents, vinca alkaloids, or epothilones.
3. Salvage chemotherapy treatment or bone marrow transplant. Salvage chemotherapy is defined as any treatment after relapse of the disease following initial chemotherapy treatment.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Costantine Albany
• Collaborators: Mayo Clinic
• Investigators: Principal Investigator: Costantine Albany, MD, Indiana University School of Medicine, Indiana University Simon Cancer Center

Publications and helpful links

General Publications

• Albany C, Dockter T, Wolfe E, Le-Rademacher J, Wagner-Johnston N, Einhorn L, Lafky JM, Smith E, Pachman D, Staff N, Ma C, Loprinzi CL, Costello BA. Cisplatin-associated neuropathy characteristics compared with those associated with other neurotoxic chemotherapy agents (Alliance A151724). Support Care Cancer. 2021 Feb;29(2):833-840. doi: 10.1007/s00520-020-05543-5. Epub 2020 Jun 4. Erratum In: Support Care Cancer. 2021 Nov;29(11):7129-7130.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2015
• Primary Completion (Actual): June 17, 2020
• Study Completion (Actual): June 17, 2020

Study Registration Dates

• First Submitted: February 5, 2016
• First Submitted That Met QC Criteria: February 8, 2016
• First Posted (Estimate): February 9, 2016

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Chemotherapy-induced peripheral neuropathy; Cisplatin-based chemotherapy
• Additional Relevant MeSH Terms: Nervous System Diseases; Neoplasms by Histologic Type; Neoplasms; Neuromuscular Diseases; Neoplasms, Germ Cell and Embryonal; Peripheral Nervous System Diseases
• Other Study ID Numbers: IUSCC-0502; 1412960547 (Other Identifier: Indiana University IRB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No