Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction

NCT01466270 | Completed Phase 2 Results DMC FDA Drug

• 3 other identifiers: IRB00019792-1U10CA081851REBACCCWFU 97211
• Study Type: interventional
• Target: 62
• Locations: 0 countries
• Sites: N/A

Brief Summary

RATIONALE: Donepezil hydrochloride may help lessen cognitive dysfunction caused by chemotherapy. PURPOSE: This phase II trial is studying donepezil hydrochloride in treating cognitive dysfunction after chemotherapy in female breast cancer survivors.

Conditions

Anxiety Disorder; Breast Cancer; Cognition Disorders; Depression; Fatigue; Sleep Disorders

Keywords

fatigue; sleep disorders; depression; anxiety disorder; cognitive/functional effects; breast cancer; cancer survivor

Outcome Measures

Primary Outcomes (2)

• Retention

  Retention is the percentage of participants who stay in the study for 24 weeks.

  24 Weeks

• Compliance

  Compliance is the percentage of pills taken while on study (based on returned diaries)

  24 weeks

Secondary Outcomes (2)

• HVLT-IR

  24 weeks

• Fatigue

  24 weeks

Study Arms (2)

Arm I

EXPERIMENTAL

Patients receive donepezil hydrochloride PO QD.

Drug: donepezil hydrochloride

Arm II

PLACEBO COMPARATOR

Patients receive placebo PO QD.

Drug: Placebo

Interventions

donepezil hydrochloride DRUG

Given PO

Also known as: Donepezil

Arm I

Placebo DRUG

Given PO

Arm II

Eligibility Criteria

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

You may qualify if:

• Adults \>18 years old.
• Female with history of invasive breast cancer
• Must have completed adjuvant chemotherapy between 1 and 5 years prior to registration
• Received at least 4 cycles of cytotoxic chemotherapy
• Documentation of prior chemotherapy
• Patients receiving ongoing hormonal therapy for breast cancer must be on the same hormonal agent for at least 3 months prior to study registration and continue for the duration of the study (9 months)
• Karnofsky Performance Status must be \> 60 or ECOG 0-2.
• Use of psychotropic medications (anti-depressants, anxiolytics, sleeping aids, narcotics) is permitted. Patient will be asked to list any that have been taken within the last 3 days on the recent medication sheet.
• Patients must be able to give informed consent to participate in the study, including signing the consent form.
• Self-reported cognitive disruption (FACT-Cog Version 3 Perceived Cognitive Impairments sub-score of \< 63)
• Negative serum pregnancy test within 10 days prior to registration for women of child-bearing potential.

You may not qualify if:

• Evidence or suspected recurrent or metastatic disease
• History of dementia, Alzheimer's disease, multi-infarct dementia or CVA (history of transient ischemic attack (TIA is allowed)
• Current use of donepezil, galantamine, rivastigmine, tacrine, memantine, methylphenidate, dextroamphetamine, or any other specific cognition enhancing drugs.are not allowed. For patients who have used these medications they must not have used them within 4 weeks prior to registration.
• Patients may not currently be taking Ketoconazole or Quinidine
• Hypersensitivity to donepezil.
• Use of investigational medications within the last 30 days.
• Prior brain metastasis
• Traumatic brain injury, multiple sclerosis or recent myocardial infarction
• History of schizophrenia, psychosis or substance abuse
• Untreated current severe depression. (Currently treated depression is permitted if treatment is stable.)
• Acute severe fatigue, chronic fatigue syndrome or fibromyalgia.
• History of hepatic or renal dysfunction or disease
• Pregnant women are excluded from this study. The effects of donepezil on the developing human fetus at the recommended therapeutic dose are unknown. For this reason and because donepezil is known to be teratogenic, women of child-bearing potential must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her study physician immediately.
• It is unknown whether donepezil is excreted in breast milk, for this reason women who are currently breast-feeding are not eligible for this study.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

MeSH Terms

Conditions

Anxiety Disorders; Breast Neoplasms; Cognition Disorders; Depression; Fatigue; Sleep Wake Disorders

Interventions

Donepezil

Condition Hierarchy (Ancestors)

Mental Disorders; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Neurocognitive Disorders; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Indans; Indenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Piperidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Dr. Doug Case
• Organization: Wake Forest School of Medicine

dcase@wakehealth.edu

336-716-1048

Study Officials

• Julia A. Lawrence

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2011
• First Posted: November 7, 2011
• Study Start: July 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: October 20, 2021
• Results First Posted: January 9, 2015

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share