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

September 18, 2020 updated by: Costantine Albany

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Time Frame: 18 months
As measured by cumulative EORTC CIPN-20 scores
18 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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