Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-24 @ 11:55 PM
NCT ID:
NCT01293851
Eligibility Criteria:
* INCLUSION CRITERIA:
Patients must meet all of the following to be eligible for enrollment:
* Age: 18 years and older
* Both male and female cancer patients will be recruited in this study. However, data will be separately assessed between males and females due to the differences in incidence, etiology and hormonal dependence which may confound the final data analyses.
* Ability to provide informed consent
* Cancer patients scheduled to undergo chemotherapy with taxane class, vinca alkaloid class, platinum compounds or bortezomib
EXCLUSION CRITERIA:
* Patients with any one of the following will be excluded:
* Unable to provide their own informed consent
* Have had prior radiotherapy
* Pre-existing documented neuropathy or risk factors for neuropathy that may confound the analysis of factors associated with CIPN such as:
* Diabetes mellitus
* Uremia
* Vitamin B12 deficiency
* Peripheral vascular disease
* Documented Thyroid dysfunction with on-going treatment. The patients who have thyroid dysfunction may also manifest the peripheral neuropathic symptoms such as numbness and tingling on their feet and hands. The medications used to treat hypothyroidism may confound the study data assessment.
* Previous history of alcoholism (beriberi) or drug abuse
* Rheumatoid arthritis
* Lupus
* Amyloidosis
* Sarcoidosis
* Other drug-induced neuropathy that may confound the analysis associated with CIPN such as:
* Thalidomide
* Isoniazid
* Trichloroethylene
* Hydralazine
* Disulfiram
* Nitrofurantoin
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01293851
Study Brief:
Protocol Section:
NCT01293851