Phase
Condition
Neurologic Disorders
Treatment
outcome measures for CIPN testing
Clinical Study ID
Ages > 18 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria
Subjects must meet all of the following inclusion criteria to be eligible for enrolment into the study:
Subjects must be candidates for neurotoxic chemotherapy at doses expected to be potentially neurotoxic (a list of neurotoxic drugs is provided in Appendix 1).
Male and female subjects who are 18 years of age or older.
Subjects freely provide informed consent by signing and dating an informed consent form prior to study entry.
Subjects must be willing to complete all study-related activities and follow-up visits required by the protocol.
Subjects must have a Karnofsky performance score greater than or equal to 70. Exclusion Criteria
Subjects presenting with any of the following will not be included in the study:
Poor prognosis, with high probability to be unable to complete the planned chemotherapy treatment.
Concomitant neurologic conditions (e.g., brain tumor, spinal or brain metastases) that would interfere or complicate the assessments.
Severe depression that in the opinion of the Investigator would complicate the assessments.
Chronic treatment with antiepileptic drugs, antidepressants and major analgesics, unless stable dosing and conditions have been reached for 3 months prior to entry.
Preventive interventions (e.g., antioxidants, cryotherapy, distal pressure).
Subjects who are currently receiving another medication other than antineoplastic chemotherapy drugs that has known potential to produce neurologic peripheral nerve toxicity (e.g. metronidazole, isoniazid, amiodarone, antiretroviral medications).
Subjects with any other condition, which, in the investigator's judgment, might decrease the chance of obtaining satisfactory data to achieve the objectives of the study.
Previous neurotoxic chemotherapy.
Study Design
Study Description
Connect with a study center
Brain and Mind Center
Sidney,
AustraliaSite Not Available
Dept. of Neurology, Medical University of Vienna
Vienna,
AustriaSite Not Available
International Centre for Diarrhoeal Disease Research
Dhaka,
BangladeshSite Not Available
Clínica AMO
Salvador,
BrazilSite Not Available
The Ottawa Hospital
Ottawa,
CanadaSite Not Available
Aarhus University Hospital
Aarhus,
DenmarkSite Not Available
Hôpital Percy
Clamart,
FranceSite Not Available
CHU Dupuytren
Limoges,
FranceSite Not Available
Center for Molecular Medicine
Cologne,
GermanySite Not Available
University of Larissa
Larissa,
GreeceSite Not Available
"Saint Andrew's" State General Hospital
Patras,
GreeceActive - Recruiting
San Gerardo Hospital
Monza, Mb 20900
ItalyActive - Recruiting
Ospedale Valduce
Como, 22063
ItalySite Not Available
Ospedale Policlinico San Martino
Genova,
ItalyActive - Recruiting
A.O.U. Policlinico "G. Martino"
Messina,
ItalySite Not Available
Padova Hospital
Padova,
ItalySite Not Available
Azienda Ospedaliera Universitaria
Verona,
ItalySite Not Available
Medical Oncoloy Unit - University of Nairobi
Nairobi,
KenyaSite Not Available
Dong-A University - Internal Medicine Dept.
Busan,
Korea, Republic ofActive - Recruiting
Centro Hospitalar Vila Nova de Gaia/Espinho
Vila Nova de Gaia,
PortugalSite Not Available
Hospital Universitari de Bellvitge-ICO L'Hospitalet
Barcelona,
SpainActive - Recruiting
University of Basel - Department of Sport, Exercise and Health
Basel,
SwitzerlandSite Not Available
Birmingham School of Nursing, University of Alabama
Birmingham, Alabama 35294
United StatesSite Not Available
Northside Hospital
Atlanta, Georgia 30342
United StatesSite Not Available
JHU
Baltimore, Maryland 21224
United StatesSite Not Available
University of Michigan School of Nursing
Ann Arbor, Michigan 48109
United StatesSite Not Available
Columbia University Irving Medical Center
New York, New York 10027
United StatesSite Not Available
Cancer Center/Wexner Medical Center - Ohio State Medical Oncology Division
Columbus, Ohio 43220
United StatesSite Not Available
Dartmouth-Hitchcock Medical Center
Lebanon, Pennsylvania 03756
United StatesSite Not Available
University of Vermont Medical Center
Burlington, Vermont 05445
United StatesSite Not Available
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