Clinical trial NCT02677727: Study of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor
Official title: A Study of the Natural History of Cisplatin-Induced Peripheral Neuropathy in Patients With Germ Cell Tumor
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Testicular Germ Cell Tumor
Keywords: Cisplatin-based chemotherapy
Chemotherapy-induced peripheral neuropathy
Lead sponsor: Indiana University
Sponsor class: OTHER
Collaborators: name: Mayo Clinic
First posted: 2016-02-09
Enrollment: 54
Sex: MALE
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are beign treated with cisplatin-based chemotherapy for testicular 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 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of neuropathy
timeFrame: 18 months
Secondary outcomes:
measure: Change in neuropathy
timeFrame: 18 months
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University Health Hospital
state: Indiana
city: Indianapolis
country: United States
facility: Indiana University Health Melvin and Bren Simon Cancer Center
state: Indiana
city: Rochester
country: United States
facility: Mayo Clinic Department of Medical Oncology
state: Minnesota
Study officials:
affiliation: Indiana University School of Medicine, Indiana University Simon Cancer Center
name: Costantine Albany, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.