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An Exploratory Trial of Donepezil and Vitamin E to Prevent Cognitive Dysfunction in Patients With Small Cell Lung Cancer (SCLC) After Cancer Treatment Which Includes Prophylatic Cranial Irradiation (PCI)

Phase 3
18 Years
Not Enrolling
Cognitive/Functional Effects, Delirium, Depression, Lung Cancer, Radiation Toxicity

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Trial Information

An Exploratory Trial of Donepezil and Vitamin E to Prevent Cognitive Dysfunction in Patients With Small Cell Lung Cancer (SCLC) After Cancer Treatment Which Includes Prophylatic Cranial Irradiation (PCI)


- Compare the interval between completion of cancer treatment that included prophylactic
cranial irradiation and onset of cognitive decline in patients with small cell lung
cancer (SCLC) treated with donepezil and vitamin E vs placebo.

- Determine the toxicity of donepezil and vitamin E in these patients.

- Determine whether preserved cognitive function favorably impacts quality of life in
these patients.

- Determine the natural history of cognitive decline in these patients after cancer

- Determine whether genotypes of apolipoprotein E predict decline in cognitive function
among patients at risk for treatment-associated dementia and whether these genotypes
predict duration of disease-free survival among patients who have achieved complete
response after treatment for SCLC.

OUTLINE: This is a randomized, double-blind, placebo-controlled study. Patients are
stratified according to cognitive function (normal vs mild to moderate dysfunction vs severe
dysfunction) and age (60 and under vs over 60).

Patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients receive oral donepezil daily and vitamin E twice daily.

- Arm II: Patients receive oral placebos according to the same schedule as the study
drugs in arm I.

All patients begin treatment within 2 weeks after completion of prophylactic cranial
irradiation. Treatment continues for a minimum of 1 month in the absence of disease
progression, unacceptable toxicity, or a 3.0 point drop on the Mini Mental State Examination
(MMSE) and/or a 5 point drop on the Blessed Dementia Scale.

Cognition is assessed using the Blessed Dementia Scale and the MMSE at baseline and then
every 3 months during study.

Quality of life and depression are assessed at baseline and then every 3 months during

Patients are followed every 6 months.

PROJECTED ACCRUAL: A total of 104 patients (52 per arm) will be accrued for this study
within 3 years.

Inclusion Criteria


- Diagnosis of small cell lung cancer (SCLC)

- Must meet one of the following conditions:

- Enrolled no more than 4 weeks before initiation of prophylactic cranial
irradiation (PCI) OR

- Enrolled no more than 10 days after initiation of PCI

- Limited or extensive stage SCLC with complete response (CR) outside chest

- Must have CR or minimal disease after completion of intended course of chemotherapy

- No disease progression since initiation of PCI

- No prior or concurrent CNS metastases



- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks


- Not specified


- Bilirubin no greater than 1.5 mg/dL


- Creatinine no greater than 2 times upper limit of normal


- No sick sinus syndrome or other symptomatic supraventricular conduction disorders
even if symptoms currently controlled by antiarrhythmics


- No history of asthma or chronic obstructive pulmonary disease requiring chronic
oxygen therapy


- No medical or psychiatric condition that would increase risk

- No seizure disorder

- No ongoing alcohol abuse


Biologic therapy:

- Not specified


- See Disease Characteristics

- No concurrent anticancer chemotherapy

Endocrine therapy:

- Not specified


- See Disease Characteristics


- Not specified


- No concurrent medications that would impair baseline cognitive function or are likely
to be dose escalated over the next few months

- No other concurrent vitamin E

Type of Study:


Study Design:

Allocation: Randomized, Masking: Double-Blind, Primary Purpose: Supportive Care

Principal Investigator

Aminah Jatoi, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Mayo Clinic


United States: Federal Government

Study ID:




Start Date:

February 2001

Completion Date:

Related Keywords:

  • Cognitive/Functional Effects
  • Delirium
  • Depression
  • Lung Cancer
  • Radiation Toxicity
  • depression
  • delirium
  • cognitive/functional effects
  • radiation toxicity
  • limited stage small cell lung cancer
  • extensive stage small cell lung cancer
  • recurrent small cell lung cancer
  • Delirium
  • Depression
  • Depressive Disorder
  • Lung Neoplasms
  • Small Cell Lung Carcinoma
  • Radiation Injuries



Mayo Clinic Cancer Center Rochester, Minnesota  55905
CCOP - Wichita Wichita, Kansas  67214-3882
CCOP - Missouri Valley Cancer Consortium Omaha, Nebraska  68131
CCOP - Illinois Oncology Research Association Peoria, Illinois  61602
CCOP - Carle Cancer Center Urbana, Illinois  61801
CCOP - Iowa Oncology Research Association Des Moines, Iowa  50309-1016
CCOP - Scottsdale Oncology Program Scottsdale, Arizona  85259-5404
CCOP - Cedar Rapids Oncology Project Cedar Rapids, Iowa  52403-1206
Siouxland Hematology-Oncology Sioux City, Iowa  51101-1733
CCOP - Merit Care Hospital Fargo, North Dakota  58122
Rapid City Regional Hospital Rapid City, South Dakota  57709
CCOP - Sioux Community Cancer Consortium Sioux Falls, South Dakota  57105-1080
Allegheny General Hospital Pittsburgh, Pennsylvania  15212-4772
Mayo Clinic Jacksonville, Florida  32224
Medcenter One Health System Bismarck, North Dakota  58501