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The Effect of Donepezil in Radiotherapy-related Cognitive Impairment.

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ClinicalTrials.gov Identifier: NCT03907371
Recruitment Status : Recruiting
First Posted : April 9, 2019
Last Update Posted : November 25, 2019
Sponsor:
Information provided by (Responsible Party):
Yamei Tang, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

Study Description
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Brief 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.

Primary outcome measure: cognitive improvement, which is determined by the difference value of ADAS-cog score before and after the treatment of donepezil.


Condition or disease Intervention/treatment Phase
Radiation Injuries Cognitive Impairment Drug: Donepezil Hydrochloride Other: Placebo Phase 2

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 238 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Donepezil in Radiotherapy-related Cognitive Impairment: a Randomized, Double-blind, Placebo-controlled Clinical Trial
Actual Study Start Date : May 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Donepezil
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.
 Drug: Donepezil Hydrochloride
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).
Placebo Comparator: Control
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.
 Other: Placebo
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).


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. global condition change [ Time Frame: Baseline to Week 24 ]
    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.

  2. changes of activities of daily living [ Time Frame: Baseline to Week 24 ]
    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.

  3. cognition change [ Time Frame: Baseline to Week 24 ]
    Efficacy of donepezil on mental statement using MMSE (Mini Mental Status Examination). The total score of MMSE is 30.

  4. psychological statement change [ Time Frame: Baseline to Week 24 ]
    Efficacy of donepezil on psychological statement, including sleep disorder, mood disorder etc. using Neuropsychiatric Inventory (NPI) total score.


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • (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.

Exclusion Criteria:

  • (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.;
  • (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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03907371


Contacts
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Contact: Yamei Tang, M.D. +86 13556001002 yameitang@hotmail.com
Contact: Yi Li, M.D. +86 15018761512 eleam2002@163.com

Locations
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China, Guangdong
Sun Yat-Sen Memorial Hospital Recruiting
Guangzhou, Guangdong, China, 510120
Contact: Yamei Tang, M.D.    +86 13556001992    yameitang@hotmail.com   
Contact: Yi Li, M.D.    +86 15018761512    eleam2002@163.com   
Sponsors and Collaborators
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Investigators
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Principal Investigator: Yamei Tang, M.D. Sun Yat-sen Memorial Hospital,Sun Yat-sen University
More Information
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Responsible Party: Yamei Tang, Professor, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
ClinicalTrials.gov Identifier: NCT03907371    
Other Study ID Numbers: 2019002
First Posted: April 9, 2019    Key Record Dates
Last Update Posted: November 25, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Radiation Injuries
Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders
Wounds and Injuries
Donepezil
 Cholinesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Cholinergic Agents
Neurotransmitter Agents
Physiological Effects of Drugs
Nootropic Agents