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

NCT02677727 | Completed DMC

• 2 other identifiers: IUSCC-05021412960547
• Study Type: observational
• Target: 54
• Locations: 1 country
• Sites: 3

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.

Conditions

Testicular Germ Cell Tumor

Keywords

Cisplatin-based chemotherapy; Chemotherapy-induced peripheral neuropathy

Outcome Measures

Primary Outcomes (1)

• Incidence of neuropathy

  As measured by cumulative EORTC CIPN-20 scores

  18 months

Secondary Outcomes (1)

• Change in neuropathy

  18 months

Interventions

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).

Eligibility Criteria

• Age: 15 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are beign treated with cisplatin-based chemotherapy for testicular germ cell tumor

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Costantine Albany: lead
• Mayo Clinic: collaborator

Study Sites (3)

Indiana University Health Hospital

Indianapolis, Indiana, 46202, United States

Location

Indiana University Health Melvin and Bren Simon Cancer Center

Indianapolis, Indiana, 46202, United States

Location

Mayo Clinic Department of Medical Oncology

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 32500206 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

DNA to use for future planned evaluations to predict patients at higher risks of developing neuropathy

MeSH Terms

Conditions

Testicular Germ Cell Tumor

Study Officials

• Costantine Albany, MD

  Indiana University School of Medicine, Indiana University Simon Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: February 5, 2016
• First Posted: February 9, 2016
• Study Start: July 1, 2015
• Primary Completion: June 17, 2020
• Study Completion: June 17, 2020
• Last Updated: September 22, 2020

Record last verified: 2020-09

Locations

US (3)