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Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated BrainUnique Dataset IDnci-data-385ClinicalTrial.gov IDNCT00369785
Clinical Trial Title
Phase III Double Blind, Placebo Controlled Study of Donepezil in the Irradiated Brain
Trial Summary and Conditions
RATIONALE: Donepezil may help lessen confusion and fatigue and improve mood and quality of life in patients who have undergone radiation therapy for brain tumors. It is not yet known whether donepezil is more effective than a placebo in lessening side effects of radiation therapy in patients with brain tumors. PURPOSE: This randomized phase III trial is studying donepezil to see how well it works in lessening side effects of radiation therapy compared with a placebo in patients who have undergone radiation therapy for brain tumors.
See data dictionary for more details.
OBJECTIVES: Primary: Evaluate whether the addition of cetuximab to a concurrent radiation-cisplatin regimen will improve progression-free survival in patients with stage III or IV squamous cell carcinoma of the oropharynx, hypopharynx, or larynx. Secondary: Determine the impact of the addition of cetuximab to a concurrent radiation-cisplatin regimen on overall survival, local-regional control, acute and late toxic effects, quality of life, and health utilities in these patients. Correlate the expression of epidermal growth factor receptor (EGFR) and its down-stream molecules with outcome in patients participating in this component of the trial. Correlate pre-treatment positron emission tomography (PET) scan findings with progression-free survival, overall survival, and local-regional control in patients participating in this component of the trial. Correlate post-treatment PET scan findings with nodal response and nodal relapse in patients participating in this component of the trial. OUTLINE: This is a randomized, controlled, multicenter study. Patients are stratified according to primary site (larynx vs non-larynx), nodal stage (N0 vs N1, N2a, N2b vs N2c, N3), Zubrod performance status (0 vs 1), use of intensity modulated radiotherapy (IMRT) (no vs yes), and pre-treatment PET/CT scan (no vs yes). Patients are randomized to 1 of 2 treatment arms. NOTE: *A neck dissection is optional for patients with multiple lymph nodes or lymph nodes > 3 cm in diameter who achieve a complete clinical and radiographic response in the neck. Quality of life is assessed at baseline, once during the last 2 weeks of treatment, at 3 and 12 months from the start of treatment, and then annually for 4 years. After completion of study treatment, patients are followed periodically for 5 years and then annually thereafter.
Primary: Memory as Quantified by HVLT-immediate Recall [ Time Frame: 24 weeks ] Memory as Quantified by the HVLT-discrimination [ Time Frame: 24 weeks ]
Below are the clinical trial(s) associated with this dataset (all links are to ClinicalTrials.Gov):
A total of 198 adult brain tumor survivors were randomly assigned to receive donepezil (5 mg for 6 weeks and 10 mg for 18 weeks) or placebo. Neurocognitive tests were assessed at baseline, 12 weeks post randomization, and 24 weeks post randomization. The primary aim of the study was to assess the effect of donepezil on a cognitive composite outcome (consisting of the average of eight standardized tests) at 24 weeks. A secondary aim was to assess the effect of donepezil on the individual tests. There was no significant effect of donepezil on the composite outcome. However, donepezil did significantly improve memory and motor speed/dexterity. This dataset contains all the data used in the publication PMID 25897156.
Available Downloads: NCT00369785-D1
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Data Dictionary: NCT00369785-D1-Data-Dictionary.pdf