Radiation InjuriesPhase 2NCT03907371
The Effect of Donepezil in Radiotherapy-related Cognitive Impairment.
A Phase 2 study testing Donepezil Hydrochloride in people with Radiation Injuries and Cognitive Impairment, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
Purpose: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the therapeutic effects of donepezil in radiotherapy-related cognitive impairment. Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Radiation Injuries, Cognitive Impairment
- What is being tested?
- Donepezil Hydrochloride
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 238 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2019to 31 Dec 2022
- Phase
- Phase 2
- Are there results?
- None posted in the registry
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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- (1) Received radiation therapy due to head and neck cancer.
- (2) Prior irradiation ≥ 1.5 years and ≤ 6 years.
- (3) Age>/= 35 years and age</=60.
- (4) Estimated life expectancy ≥ 12 months.
- (5) Cognitive impairment ≥ 4 weeks, with MMSE total score ≤26, or MoCA total score ≤ 25.
- (6) Routine laboratory studies: normal bilirubin, normal aspartate aminotransferase (AST or SGOT), normal alanine aminotransferase (ALT), normal creatinine, normal white-cell count; normal neutrophils count, normal platelets count; Hb >/=110 gram per millilitres; PT, APTT, INR in a normal range.
- (7) Constant caregivers who well understand and have willingness to sign a written informed consent document.
Who cannot join
- (1) evidence of tumor metastasis, recurrence, or invasion;
- (2) evidence of very high intracranial pressure that suggests brain hernia and need surgery;
- (3) previous treatment with donepezil or other medications for cognitive impairment;
- (4) history of mental disorders, epilepsy, cognitive impairment before radiotherapy;
- (5) history of stroke, or high risk of vascular dementia;
- (6) family history of Alzheimer's disease, Pick's disease, etc.;
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- (7) history of severe head trauma;
- (8) clinically significant active disease, e.g. New York Heart Association Grade II or greater congestive heart failure, serious and inadequately controlled cardiac arrhythmia, bradycardia, significant vascular disease, severe infection;
- (9) history of allergy to relevant drugs;
- (10) pregnancy, lactation, or fertility program in the following 12 months;
- (11) participation in other experimental studies.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Sun Yat-Sen Memorial Hospital
Guangzhou, Guangdong, 510120
Yamei Tang, M.D., +86 13556001992, yameitang@hotmail.com
Yi Li, M.D., +86 15018761512, eleam2002@163.com
About this study
Official title: The Effect of Donepezil in Radiotherapy-related Cognitive Impairment: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Purpose: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the therapeutic effects of donepezil in radiotherapy-related cognitive impairment.
Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang.
Primary outcome measure: cognitive improvement, which is determined by the difference value of ADAS-cog score before and after the treatment of donepezil.
Read the detailed description
Application of radiotherapy to patients with head and neck cancer is a mainstay treatment in contemporary oncology practice. However, patients who received radiation are vulnerable to development of cognitive impairment. There is no acknowledged and effective standard treatment for radiotherapy-related cognitive impairment. The investigators supposed that donepezil, as a cholinesterase inhibitor, would relieve radiotherapy-related cognitive impairment after head and neck cancer, and would improve the life quality for these patients and their families.
Primary objectives: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of donepezil on cognition in radiotherapy-related cognitive impairment.
Secondary objectives:
To evaluate the effect of donepezil on sleep disorder, mood disorder, activities of daily living, and safety in patients with radiotherapy-related cognitive impairment.
OUTLINE: This is randomized, double-blind, placebo-controlled clinical trial. Patients will be enrolled and administrated with donepezil or placebo. Donepezil will be supplied as 10 mg per pill to be taken by mouth. Placebo will be supplied as substitute of 10 mg donepezil per pill to be taken by mouth.
Patients will be screened, consented, enrolled and have a washout period for 6 weeks. Then these patients will be randomized to two arms.
Arm І: Patients receive donepezil with a dosage of 5 milligram at 8 am for one week (Week 1), then 10 milligram at 8 am for 23 weeks (Week 2-24), in the absence of unacceptable toxicity or severe deterioration.
Arm ІI: Patients receive placebo with a dosage of one half pill at 8 am for one week (Week 1), then one pill at 8 am for 23 weeks (Week 2-24), in the absence of unacceptable toxicity or severe deterioration.
- Conditions
- Radiation Injuries, Cognitive Impairment
- Being tested
- Donepezil Hydrochloride, Placebo
- Medical subject headings
- Radiation Injuries, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Donepezil HydrochlorideDrug
Donepezil will be used with a dosage of 5 milligram at 8 am for one week (Week 1), then 10 milligram at 8 am for 23 weeks (Week 2-24).
PlaceboOther
Placebo will be used with a dosage of one half pill at 8 am for one week (Week 1), then one pill at 8 am for 23 weeks (Week 2-24).
| Study group | Role | What they receive |
|---|---|---|
| Donepezil | Experimental | Patients receive donepezil with a dosage of 5 milligram at 8 am for one week (Week 1), then 10 milligram at 8 am for 23 weeks (Week 2-24), in the absence of unacceptable toxicity or severe deterioration. Receives: Drug: Donepezil Hydrochloride |
| Control | Placebo comparator | Patients receive placebo with a dosage of one half pill at 8 am for one week (Week 1), then one pill at 8 am for 23 weeks (Week 2-24), in the absence of unacceptable toxicity or severe deterioration. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
cognitive change
Cognitive change, which is determined by the difference value of ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) before and after the treatment of donepezil. The rating of ADAS-cog is made on 6-point scale rating from 0 to 5 in 12 domains.
Measured: Baseline to Week 24
Secondary outcomes (4)
global condition change
Efficacy of donepezil on global condition using CIBIC-plus (Clinician's Interview-Based Impression of Change plus). The rating is made on a 7-point scale ranging from "1 = marked improvement" to "7 = marked worsening". A score of "4" indicates no change.
Measured: Baseline to Week 24
changes of activities of daily living
Efficacy of donepezil on activities of daily living using ADL (Activities of Daily Living). Total score is from 0 to 54. The higher score, the lower impairment.
Measured: Baseline to Week 24
cognition change
Efficacy of donepezil on mental statement using MMSE (Mini Mental Status Examination). The total score of MMSE is 30.
Measured: Baseline to Week 24
psychological statement change
Efficacy of donepezil on psychological statement, including sleep disorder, mood disorder etc. using Neuropsychiatric Inventory (NPI) total score.
Measured: Baseline to Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2019
- Study start1 May 2019
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Radiation InjuriesStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe 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
- 238 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
- Investigators
- Yamei Tang, M.D., Principal investigator, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03907371
- Sponsor's protocol ID
- 2019002
- Status last verified
- Nov 2019
- First submitted
- 27 Mar 2019
- Last updated
- 25 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Donepezil in Radiotherapy-related Cognitive Impairment: a Randomized, Double-blind, Placebo-controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03907371
- Acronym / sponsor ID
- 2019002
- Conditions
- Radiation Injuries, Cognitive Impairment
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 238 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- 1 May 2019 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 9 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the therapeutic effects of donepezil in radiotherapy-related cognitive impairment.
Further study details as provided by Sun Yat-sen Memorial Hospital, Sun Yat-sen University / Yameitang.
Primary outcome measure: cognitive improvement, which is determined by the difference value of ADAS-cog score before and after the treatment of donepezil.
Detailed description
Application of radiotherapy to patients with head and neck cancer is a mainstay treatment in contemporary oncology practice. However, patients who received radiation are vulnerable to development of cognitive impairment. There is no acknowledged and effective standard treatment for radiotherapy-related cognitive impairment. The investigators supposed that donepezil, as a cholinesterase inhibitor, would relieve radiotherapy-related cognitive impairment after head and neck cancer, and would improve the life quality for these patients and their families.
Primary objectives: This randomized, double-blind, placebo-controlled clinical trial aims to evaluate the efficacy of donepezil on cognition in radiotherapy-related cognitive impairment.
Secondary objectives:
To evaluate the effect of donepezil on sleep disorder, mood disorder, activities of daily living, and safety in patients with radiotherapy-related cognitive impairment.
OUTLINE: This is randomized, double-blind, placebo-controlled clinical trial. Patients will be enrolled and administrated with donepezil or placebo. Donepezil will be supplied as 10 mg per pill to be taken by mouth. Placebo will be supplied as substitute of 10 mg donepezil per pill to be taken by mouth.
Patients will be screened, consented, enrolled and have a washout period for 6 weeks. Then these patients will be randomized to two arms.
Arm І: Patients receive donepezil with a dosage of 5 milligram at 8 am for one week (Week 1), then 10 milligram at 8 am for 23 weeks (Week 2-24), in the absence of unacceptable toxicity or severe deterioration.
Arm ІI: Patients receive placebo with a dosage of one half pill at 8 am for one week (Week 1), then one pill at 8 am for 23 weeks (Week 2-24), in the absence of unacceptable toxicity or severe deterioration.
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 |
|---|---|---|
| Donepezil | Experimental | Drug: Donepezil HydrochloridePatients receive donepezil with a dosage of 5 milligram at 8 am for one week (Week 1), then 10 milligram at 8 am for 23 weeks (Week 2-24), in the absence of unacceptable toxicity or severe deterioration. |
| Control | Placebo comparator | Other: PlaceboPatients receive placebo with a dosage of one half pill at 8 am for one week (Week 1), then one pill at 8 am for 23 weeks (Week 2-24), in the absence of unacceptable toxicity or severe deterioration. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- (1) Received radiation therapy due to head and neck cancer.
- (2) Prior irradiation ≥ 1.5 years and ≤ 6 years.
- (3) Age>/= 35 years and age</=60.
- (4) Estimated life expectancy ≥ 12 months.
- (5) Cognitive impairment ≥ 4 weeks, with MMSE total score ≤26, or MoCA total score ≤ 25.
Key exclusion criteria (11 listed)
- (1) evidence of tumor metastasis, recurrence, or invasion;
- (2) evidence of very high intracranial pressure that suggests brain hernia and need surgery;
- (3) previous treatment with donepezil or other medications for cognitive impairment;
- (4) history of mental disorders, epilepsy, cognitive impairment before radiotherapy;
- (5) history of stroke, or high risk of vascular dementia;
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 HydrochlorideDonepezil will be used with a dosage of 5 milligram at 8 am for one week (Week 1), then 10 milligram at 8 am for 23 weeks (Week 2-24). | Drug | Donepezil |
| PlaceboPlacebo will be used with a dosage of one half pill at 8 am for one week (Week 1), then one pill at 8 am for 23 weeks (Week 2-24). | Other | Control |
Primary outcome
cognitive change
Time frame: Baseline to Week 24
Cognitive change, which is determined by the difference value of ADAS-cog (Alzheimer's Disease Assessment Scale-cognitive subscale) before and after the treatment of donepezil. The rating of ADAS-cog is made on 6-point scale rating from 0 to 5 in 12 domains.
4 secondary outcomes
global condition change
Time frame: Baseline to Week 24
changes of activities of daily living
Time frame: Baseline to Week 24
cognition change
Time frame: Baseline to Week 24
psychological statement change
Time frame: Baseline to Week 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2019.
- Individual participant dataSharing planned: Undecided
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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.
Yamei Tang, M.D. principal investigator
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Donepezil Hydrochloride in people with Radiation Injuries and Cognitive Impairment, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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 7 inclusion and 11 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: status not confirmed, as of the sponsor's last update on 25 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yamei Tang, M.D. (+86 13556001002, yameitang@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cognitive change (time frame: Baseline to Week 24). 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 25 Nov 2019.