Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT03324945 : Chemotherapy-Induced Cognitive Impairment in Ovarian Cancer Patients
PhasePhase 2
AgesMin: 18 Years Max: N/A
Eligibility
Inclusion Criteria:

1. Patients with any stage epithelial ovarian cancer, including cancers arising from the
fallopian tube and primary peritoneal cancer, or patients with other gynecologic
malignancy (any stage), who are chemotherapy-naïve, and scheduled to undergo at least
6 cycles of intravenous platinum/taxane-based chemotherapy.

2. Patients who are receiving other investigational agents will be permitted on study, at
the discretion of the principal investigator.

3. Patients must have adequate bone marrow, renal, hepatic, and sensory neurologic
function to be eligible to receive platinum/taxane-based chemotherapy.

4. Patients must have a World Health Organization Performance Status of ? 2.

5. Age ?18 years.

6. Ability to understand and the willingness to sign an approved written informed consent
document.

Exclusion Criteria:

1. Patients who have received prior cytotoxic chemotherapy are ineligible. Patients may
have received prior adjuvant hormonal therapy for localized breast cancer, provided
that it was completed prior to registration, and that the patient remains free of
recurrent or metastatic disease.

2. Patients with known brain metastases should be excluded from this clinical trial
because of their poor prognosis and because they often develop progressive neurologic
dysfunction that would confound the evaluation of neurologic outcomes and other
adverse events.

3. Patients with underlying dementia (or on medications to treat Alzheimer's disease such
as donepezil, rivastigmine, galantamine, tacrine, or memantine), encephalopathy, or
other neurological disorder known to adversely affect cognition (such as epilepsy or
prior stroke) are excluded. (Patients with depression or anxiety are not excluded).

4. Patients will be excluded from fMRI testing if they are left-handed, claustrophobic,
have a pacemaker, or have metal implants. Patients not undergoing fMRI testing may
still enroll in clinical trial, including the ERP testing, if all other eligibility
criteria are met.

5. Patients who are pregnant or nursing are excluded. Pregnant women are excluded from
this study because cytotoxic chemotherapy has the potential for teratogenic or
abortifacient effects. Because there is an unknown but potential risk for adverse
events in nursing infants secondary to treatment of the mother with cytotoxic
chemotherapy, breastfeeding should be discontinued if the mother is treated with
cytotoxic chemotherapy.

6. Patients who are non-English speaking are excluded because of the inability to
adequately administer neurocognitive testing in non-English languages.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT03324945      |      Link to official Clinicaltrials.gov listing
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