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

Testicular Germ Cell Tumor Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02677727
• Other study ID #: IUSCC-0502
• Secondary ID: 1412960547
• Status: Completed
• Start date: July 1, 2015
• Est. completion date: June 17, 2020

Study information

• Verified date: September 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: June 17, 2020
• Est. primary completion date: June 17, 2020
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 15 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Neoplasms, Germ Cell and Embryonal
• Peripheral Nervous System Diseases
• Testicular Germ Cell Tumor

Intervention

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).

Locations

Country	Name	City	State
United States	Indiana University Health Hospital	Indianapolis	Indiana
United States	Indiana University Health Melvin and Bren Simon Cancer Center	Indianapolis	Indiana
United States	Mayo Clinic Department of Medical Oncology	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Costantine Albany	Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of neuropathy	As measured by cumulative EORTC CIPN-20 scores	18 months
Secondary	Change in neuropathy	As measured by change in EORTC CIPN-20 scores	18 months