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NCT Number: NCT02677727

Study 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.

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Key information

Age range

15 year and older

Sex eligibility

Male

Study type

Observational

Primary location

Indiana University Health Hospital, Indianapolis, Indiana, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

EORTC QLQ-CIPN20

Other

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).

Primary outcomes

  1. Incidence of neuropathy

    Time frame: 18 months

    As measured by cumulative EORTC CIPN-20 scores

Secondary outcomes

  1. Change in neuropathy

    Time frame: 18 months

    As measured by change in EORTC CIPN-20 scores

Sponsors and collaborators

Lead sponsor

Costantine Albany

Other

Collaborators

  • Mayo Clinic

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2020
Study completion
2020
First posted
Feb 9, 2016
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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