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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00006349
Other study ID # NCCTG-N99C5
Secondary ID CDR0000068206NCI
Status Completed
Phase Phase 3
First received October 4, 2000
Last updated July 12, 2016
Start date February 2001
Est. completion date January 2007

Study information

Verified date July 2016
Source Alliance for Clinical Trials in Oncology
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

RATIONALE: Donepezil and vitamin E may be able to decrease side effects caused by radiation therapy given to prevent brain metastases in patients with small cell lung cancer. It is not yet known if donepezil and vitamin E are effective in preventing side effects caused by radiation therapy to the head.

PURPOSE: Randomized phase III trial to determine the effectiveness of donepezil and vitamin E in preventing side effects caused by radiation therapy given to prevent brain metastases in patients who have small cell lung cancer.


Description:

OBJECTIVES:

- 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 treatment.

- 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 study.

Patients are followed every 6 months.


Recruitment information / eligibility

Status Completed
Enrollment 9
Est. completion date January 2007
Est. primary completion date January 2005
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility DISEASE CHARACTERISTICS:

- 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 allowed

- 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

PATIENT CHARACTERISTICS:

Age:

- 18 and over

Performance status:

- ECOG 0-2

Life expectancy:

- At least 12 weeks

Hepatic:

- Bilirubin no greater than 1.5 mg/dL

Renal:

- Creatinine no greater than 2 times upper limit of normal

Cardiovascular:

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

Pulmonary:

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

Other:

- No medical or psychiatric condition that would increase risk

- No seizure disorder

- No ongoing alcohol abuse

PRIOR CONCURRENT THERAPY:

Chemotherapy:

- See Disease Characteristics

- No concurrent anticancer chemotherapy

Other:

- 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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Supportive Care


Intervention

Dietary Supplement:
vitamin E

Drug:
donepezil hydrochloride

Other:
placebo


Locations

Country Name City State
United States Medcenter One Health System Bismarck North Dakota
United States CCOP - Cedar Rapids Oncology Project Cedar Rapids Iowa
United States CCOP - Iowa Oncology Research Association Des Moines Iowa
United States CCOP - Merit Care Hospital Fargo North Dakota
United States Mayo Clinic Jacksonville Florida
United States CCOP - Missouri Valley Cancer Consortium Omaha Nebraska
United States CCOP - Illinois Oncology Research Association Peoria Illinois
United States Allegheny General Hospital Pittsburgh Pennsylvania
United States Rapid City Regional Hospital Rapid City South Dakota
United States Mayo Clinic Cancer Center Rochester Minnesota
United States CCOP - Scottsdale Oncology Program Scottsdale Arizona
United States Siouxland Hematology-Oncology Sioux City Iowa
United States CCOP - Sioux Community Cancer Consortium Sioux Falls South Dakota
United States CCOP - Carle Cancer Center Urbana Illinois
United States CCOP - Wichita Wichita Kansas

Sponsors (2)

Lead Sponsor Collaborator
Alliance for Clinical Trials in Oncology National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Jatoi A, Kahanic SP, Frytak S, Schaefer P, Foote RL, Sloan J, Petersen RC. Donepezil and vitamin E for preventing cognitive dysfunction in small cell lung cancer patients: preliminary results and suggestions for future study designs. Support Care Cancer. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 6 months No
Secondary Quality of life Up to 6 months No
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