Chemotherapy-Induced Cognitive Impairment in Ovarian Cancer Patients

NCT03324945 | Completed DMC

• 1 other identifier: MCC-15-GYN-333
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

Chemotherapy-induced cognitive impairment (CICI), also known as "chemobrain," is a spectrum of neurocognitive deficits experienced during and after the administration of chemotherapy for cancer. The incidence of CICI is significant, affecting anywhere from 25 to 75% of survivors, and the biologic basis is unknown. This novel study is designed to address the questions of incidence and biological cause for CICI, while gaining a better understanding of the structural and functional effects of chemotherapy on the brain.

Conditions

Chemotherapy-induced Cognitive Impairment

Outcome Measures

Primary Outcomes (1)

• Reliable Change Index (RCI)

  To address the primary aim, RCI (which is essentially a z-score) for each patient will be calculated from the pre-, post-chemotherapy Montreal Cognitive Assessment (MoCA) test results. Then a Wilcoxon signed rank test will be applied to the RCI values with corresponding 95% confidence intervals.

  4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)

Secondary Outcomes (2)

• Assess the correlation between biologic markers of oxidative stress and neurocognitive test results.

  4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)

• Assess the correlation between brain imaging and neurocognitive test results

  4 weeks after completing cycle #6 chemotherapy (each cycle is 21 days)

Study Arms (1)

Neurocognitive Assessment +/- FMRI

EXPERIMENTAL

All participants receive pre- and post-chemotherapy neurocognitive assessments. A sequentially-assigned subset also receive pre- and post-chemotherapy Functional Magnetic Resonance Imaging (FMRI) procedures.

Behavioral: Neurocognitive assessments

Interventions

Neurocognitive assessments BEHAVIORAL

Baseline and post-chemotherapy neurocognitive testing. A sequentially-assigned subset of participants also receive baseline and post-chemotherapy neuroimaging (FMRI)

Neurocognitive Assessment +/- FMRI

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Patients must have adequate bone marrow, renal, hepatic, and sensory neurologic function to be eligible to receive platinum/taxane-based chemotherapy.
• Patients must have a World Health Organization Performance Status of ≤ 2.
• Age ≥18 years.
• Ability to understand and the willingness to sign an approved written informed consent document.

You may not qualify if:

• 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.
• Patients undergoing neoadjuvant chemotherapy with planned interval cytoreductive surgery and adjuvant therapy are not included in this group.
• Patients who are receiving any other investigational agents are excluded.
• 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.
• With the exception of non-melanoma skin cancer and other specific malignancies noted above, patients with other invasive malignancies who had (or have) any evidence of the other cancer present within the last five years or whose previous cancer treatment contraindicates this therapy are excluded.
• 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).
• 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.
• 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.
• Patients who are non-English speaking are excluded because of the inability to adequately administer neurocognitive testing in non-English languages.

Sponsors & Collaborators

• Rachel Miller: lead
• Office of US Army Medical Research and Material Command: collaborator

Study Sites (1)

University of Kentucky Markey Cancer Center

Lexington, Kentucky, 40536, United States

Location

MeSH Terms

Conditions

Chemotherapy-Related Cognitive Impairment

Condition Hierarchy (Ancestors)

Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Cognitive Dysfunction; Cognition Disorders; Neurocognitive Disorders; Mental Disorders

Study Officials

• Rachel W Miller, MD

  University of Kentucky

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: October 30, 2017
• Study Start: August 1, 2016
• Primary Completion: October 12, 2018
• Study Completion: April 1, 2019
• Last Updated: November 12, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)