Testicular Germ Cell Tumor
Conditions
Keywords
Cisplatin-based chemotherapy, Chemotherapy-induced peripheral neuropathy
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.
Interventions
OTHEREORTC 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).
Sponsors
Mayo Clinic
Costantine Albany
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of neuropathy | 18 months | As measured by cumulative EORTC CIPN-20 scores |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in neuropathy | 18 months | As measured by change in EORTC CIPN-20 scores |
Countries
United States
Outcome results
None listed