Anxiety DisorderPhase 2NCT01466270
Study of Donepezil in Female Breast Cancer Survivors With Cognitive Dysfunction
A Phase 2 study testing donepezil hydrochloride in people with Anxiety Disorder and Breast Cancer, run by Wake Forest University Health Sciences.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Anxiety Disorder, Breast Cancer, Cognition Disorders
- What is being tested?
- donepezil hydrochloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- No sites listed yet
- Study dates
- Jul 2012to 1 Oct 2013
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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.
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- 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.
About this study
Official title: A Feasibility Study of Donepezil in Female Breast Cancer Survivors With Self-Reported Cognitive Dysfunction Following Chemotherapy
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.
Read the detailed description
OBJECTIVES:
Primary
- Determine the feasibility of conducting a randomized placebo-controlled clinical trial for cognitive symptoms in female breast cancer survivors.
Secondary
- Estimate the variability of the clinical outcomes (FACT-Cognition Perceived Cognitive Impairment subscale, neurocognitive battery, FACIT-Fatigue, FACT Cog Total Score, PROMIS Fatigue, Epworth Sleepiness Scale, Beck Depression Inventory, Beck Anxiety Inventory, and RAND Short Form-36).
- Estimate the within patient correlation over time of the clinical outcomes.
- Obtain preliminary estimates of the effect of donepezil on the primary and secondary outcome variables.
- Correlate the reports of fatigue, sleep disturbance, and mood with measures of cognitive symptoms and neurocognitive test performance.
- Document the severity of cognitive symptoms and functional impairment in female breast cancer survivors who enroll on this pilot study.
- Correlate cognitive symptoms with cognitive test performance.
- Document the toxicities associated with donepezil hydrochloride use.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to menopausal status (pre- vs peri-/post-menopausal) and time since end of chemotherapy (12-36 months vs 36.01-60 months).
Arm I: Patients receive donepezil hydrochloride orally (PO) once daily (QD).
Arm II: Patients receive placebo PO QD.
In both arms treatment continues for 24 weeks.
Patients complete the entire battery of neurocognitive tests and questionnaires (FACT-Cognition Perceived Cognitive Impairment subscale, neurocognitive battery, FACIT-Fatigue, FACT Cog Total Score, PROMIS Fatigue, Epworth Sleepiness Scale, Beck Depression Inventory, Beck Anxiety Inventory, and RAND Short Form-36) at baseline (pre-treatment), 24 weeks (end of medication), and 36 weeks (end of wash-out).
After completion of therapy, patients are followed at 12 weeks.
- Conditions
- Anxiety Disorder, Breast Cancer, Cognition Disorders, Depression, Fatigue, Sleep Disorders
- Being tested
- donepezil hydrochloride, Placebo
- Keywords
- fatigue, sleep disorders, depression, anxiety disorder, cognitive/functional effects, breast cancer, cancer survivor
- Medical subject headings
- Anxiety Disorders, Breast Neoplasms, Cognition Disorders, Depression, Fatigue, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
donepezil hydrochlorideDrug
Also called Donepezil
Given PO
PlaceboDrug
Given PO
| Study group | Role | What they receive |
|---|---|---|
| Arm I | Experimental | Patients receive donepezil hydrochloride PO QD. Receives: Drug: donepezil hydrochloride |
| Arm II | Placebo comparator | Patients receive placebo PO QD. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Retention
Retention is the percentage of participants who stay in the study for 24 weeks.
Measured: 24 Weeks
Compliance
Compliance is the percentage of pills taken while on study (based on returned diaries)
Measured: 24 weeks
Secondary outcomes (2)
HVLT-IR
Hopkins verbal learning test - immediate recall is the number of words (of 12) than can be remembers during three tries. The total score ranges from 0 to 36. Higher is better.
Measured: 24 weeks
Fatigue
Fatigue is quantified by the FACIT-Fatigue scale. It consists of 13 questions answered on a 0 to 4 point scale. The fatigue score is the sum of the responses (some reverse scored) so that higher values represent less fatigue.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2011 (estimated)
- Study startJul 2012
- Primary completion1 Oct 2013
- Study completion1 Oct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Julia A. Lawrence, Principal investigator, Wake Forest University Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01466270
- Sponsor's protocol ID
- IRB00019792-1
- Other IDs
- U10CA081851, REBACCCWFU 97211
- Status last verified
- Sep 2021
- First submitted
- 2 Nov 2011
- Last updated
- 20 Oct 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Donepezil in Female Breast Cancer Survivors With Self-Reported Cognitive Dysfunction Following Chemotherapy
- ClinicalTrials.gov ID
- NCT01466270
- Acronym / sponsor ID
- IRB00019792-1
- 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
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jul 2012 (actual)
- Primary completion
- 1 Oct 2013 (actual)
- Study completion
- 1 Oct 2013 (actual)
- First posted
- 7 Nov 2011 (estimated)
- Results
- Posted 9 Jan 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
Primary
- Determine the feasibility of conducting a randomized placebo-controlled clinical trial for cognitive symptoms in female breast cancer survivors.
Secondary
- Estimate the variability of the clinical outcomes (FACT-Cognition Perceived Cognitive Impairment subscale, neurocognitive battery, FACIT-Fatigue, FACT Cog Total Score, PROMIS Fatigue, Epworth Sleepiness Scale, Beck Depression Inventory, Beck Anxiety Inventory, and RAND Short Form-36).
- Estimate the within patient correlation over time of the clinical outcomes.
- Obtain preliminary estimates of the effect of donepezil on the primary and secondary outcome variables.
- Correlate the reports of fatigue, sleep disturbance, and mood with measures of cognitive symptoms and neurocognitive test performance.
- Document the severity of cognitive symptoms and functional impairment in female breast cancer survivors who enroll on this pilot study.
- Correlate cognitive symptoms with cognitive test performance.
- Document the toxicities associated with donepezil hydrochloride use.
OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to menopausal status (pre- vs peri-/post-menopausal) and time since end of chemotherapy (12-36 months vs 36.01-60 months).
Arm I: Patients receive donepezil hydrochloride orally (PO) once daily (QD).
Arm II: Patients receive placebo PO QD.
In both arms treatment continues for 24 weeks.
Patients complete the entire battery of neurocognitive tests and questionnaires (FACT-Cognition Perceived Cognitive Impairment subscale, neurocognitive battery, FACIT-Fatigue, FACT Cog Total Score, PROMIS Fatigue, Epworth Sleepiness Scale, Beck Depression Inventory, Beck Anxiety Inventory, and RAND Short Form-36) at baseline (pre-treatment), 24 weeks (end of medication), and 36 weeks (end of wash-out).
After completion of therapy, patients are followed at 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I | Experimental | Drug: donepezil hydrochloridePatients receive donepezil hydrochloride PO QD. |
| Arm II | Placebo comparator | Drug: PlaceboPatients receive placebo PO QD. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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
Key exclusion criteria (14 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| donepezil hydrochlorideAlso: DonepezilGiven PO | Drug | Arm I |
| PlaceboGiven PO | Drug | Arm II |
Primary outcome
Retention
Time frame: 24 Weeks
Retention is the percentage of participants who stay in the study for 24 weeks.
Compliance
Time frame: 24 weeks
Compliance is the percentage of pills taken while on study (based on returned diaries)
2 secondary outcomes
HVLT-IR
Time frame: 24 weeks
Fatigue
Time frame: 24 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julia A. Lawrence principal investigator
Wake Forest University Health Sciences
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing donepezil hydrochloride in people with Anxiety Disorder and Breast Cancer, run by Wake Forest University Health Sciences.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Retention (time frame: 24 Weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Oct 2021.