Study of Cisplatin-Induced Peripheral Neuropathy in Patie... | NCT02677727

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

NCT02677727

Sponsor

Costantine Albany

Status

Completed

Last Update Posted

Sep 22, 2020Actual

Enrollment

54Actual

Phase

Not provided

Conditions

Testicular Germ Cell Tumor

Interventions

EORTC QLQ-CIPN20

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
1412960547	Other Identifier	Indiana University IRB

Status Module

Record Verification Date

Sep 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 1, 2015Actual

Primary Completion Date

Jun 17, 2020Actual

Completion Date

Jun 17, 2020Actual

First Submitted Date

Feb 5, 2016

First Submission Date that Met QC Criteria

Feb 8, 2016

First Posted Date

Feb 9, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 18, 2020

Last Update Posted Date

Sep 22, 2020Actual

Name	Class
Mayo Clinic	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

54Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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).

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Incidence of neuropathy	As measured by cumulative EORTC CIPN-20 scores	18 months

Secondary Outcomes

Measure	Description	Time Frame
Change in neuropathy	As measured by change in EORTC CIPN-20 scores	18 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion criteria:

15 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.

Exclusion criteria:

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.

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Costantine Albany, MD	Indiana University School of Medicine, Indiana University Simon Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Indiana University Health Hospital		Indianapolis	Indiana	46202	United States
Indiana University Health Melvin and Bren Simon Cancer Center

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
32500206	Derived	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.