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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

54 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-07-01

Study Completion Date

2020-06-17

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study of Gemcitabine, Oxaliplatin, and Paclitaxel in Patients With Refractory Germ Cell Carcinoma

NCT00183820

Testicular Cancer Germ Cell Neoplasm

COMPLETED PHASE2

Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations

NCT03609216

Infiltrating Bladder Urothelial Carcinoma Stage II Bladder Urothelial Carcinoma Stage III Bladder Urothelial Carcinoma

RECRUITING PHASE2

Study to Investigate the Chemotherapy-Induced Peripheral Neuropathy (CIPN) Onset-Suppressing Effect and Safety of ONO-2910 in Patients With Breast Cancer Receiving Weekly Paclitaxel

NCT06538272

CIPN - Chemotherapy-Induced Peripheral Neuropathy

COMPLETED PHASE2

Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.

NCT00191620

Non-Small-Cell Lung Carcinoma

COMPLETED PHASE2

Conventional Dose Versus High Dose Sequential Chemotherapy for Poor Prognosis Germ Cell Tumors

NCT02161692

Testicular Neoplasms Germ Cell Tumors

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Testicular Germ Cell Tumor

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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).

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

15 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No