Testing Ramipril to Prevent Memory Loss in People With Glioblastoma
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|ClinicalTrials.gov Identifier: NCT03475186|
Recruitment Status : Recruiting
First Posted : March 23, 2018
Last Update Posted : July 15, 2019
|Condition or disease||Intervention/treatment||Phase|
|Glioblastoma Radiotherapy; Complications Cognitive Decline Chemoradiation||Drug: Ramipril||Phase 2|
|Study Type :||Interventional|
|Estimated Enrollment :||75 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Single Arm, Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy|
|Actual Study Start Date :||March 25, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||August 2021|
Ramipril will be taken once daily by mouth. It will be titrated during the first 3 weeks of chemoradiation to the highest tolerable dose (2.5-5 mg). This dose will be taken each day until 4 months post-chemoradiation treatment (22 weeks).
2.5 - 5 mg oral, 1x daily for 22 weeks
- Change from Baseline Neurocognitive Function at 10 weeks - Hopkins Verbal Learning Test-Revised (HVLT-R) [ Time Frame: Baseline,10 weeks ]HVLT-R measures verbal learning and memory. It consists of a 12-item word list which is read to subjects on three successive learning trials. Free recall scores are recorded for each learning trial. Scores for immediate recall (total of three trials), delayed recall (total number of words recalled after 20 minutes), and recognition (total number of words correctly identified) will be the variables derived from the HVLT-R.
- Change from Baseline Neurocognitive Function at 10 weeks - Trail Making Test Part A and B (TMT A & B) [ Time Frame: Baseline,10 weeks ]Part A of the TMT measures attention and visual motor skills and processing speed and requires subjects to connect 25 numbered circles in the proper sequence (1-2-3-…) as quickly as possible. TMT-B is similar except subjects are required to connect dots in an alternating numerical and alphabetical sequence (1-A-2-B-…). TMT-B with its added complexity and set shifting requirements is a widely used measure of executive function. The score for TMT-A and TMT-B is the total time in seconds required to complete the task. Scores can also be generated for number of errors and number of circles correctly connected.
- Change from Baseline Neurocognitive Function at 10 weeks - Controlled Oral Word Association Test (COWA) [ Time Frame: Baseline,10 weeks ]The COWA measures speed of mental processing, verbal fluency, and executive function. Subjects are asked to name as many words as possible all beginning with a specified letter. A total of three trials are administered, each with a different letter (F-A-S). The score on the COWA is the total number of words named across the three trials minus repetitions.
- Efficacy of Ramipril of Neurocognitive Function at Baseline - Shipley Institute of Living Scale-Version 2 Vocabulary [ Time Frame: Baseline ]Provides an assessment of premorbid intellectual functioning comparable to a verbal IQ and thus is a proxy for cognitive reserve. This vocabulary test requires respondents to read a target word and select one of four words that most closely means the same thing. Score is total correct of 40 items and will be used in conjunction with the other neurocognitive results.
- Retention Rate at 10 weeks [ Time Frame: 10 weeks ]Measured by the percent of patients who took 75% of the Ramipril doses and completed the neurocognitive battery of tests
- Efficacy of Ramipril on Non-Memory Cognitive Functions-EORTC Quality of Life Questionnaire-Core 30/Brain Cancer Module-20 (EORTCQLQ30/BN20) [ Time Frame: Baseline, 6 weeks, 10 weeks, 22 weeks ]A 50-item questionnaire with a 20-item brain cancer specific section, used to assess the physical and psychosocial functioning and symptom experience. All of the scales and single-item measures range in score from 0 to 100 with standardization.
- Estimate Time of Neurocognitive Decline- HVLT-R [ Time Frame: Baseline - 22 weeks ]Measured by the first significant decline of the HVLT-R.
- Estimate Time of Neurocognitive Decline- TMT A & B [ Time Frame: Baseline - 22 weeks ]Measured by the first significant decline of the TMT A & B
- Estimate Time of Neurocognitive Decline- COWA [ Time Frame: Baseline - 22 weeks ]Measured by the first significant decline of the COWA
- Determine Presence of Apolipoprotein Epsilon (ApoE) [ Time Frame: Baseline ]Measured by quantitative polymerase chain reaction (PCR) using patient serum via a blood test
- Efficacy of neurocognitive function in surviving patients- HVLT-R [ Time Frame: 22 weeks ]Comparison of HVLT-R results between groups at study end.
- Efficacy of neurocognitive function in surviving patients- TMT A & B [ Time Frame: 22 weeks ]Comparison of TMT A & B results between groups at study end.
- Efficacy of neurocognitive function in surviving patients- COWA [ Time Frame: 22 weeks ]Comparison of COWA results between groups at study end.
- Efficacy of neurocognitive function in surviving patients- EORTCQLQ30/BN20 [ Time Frame: 22 weeks ]Comparison of EORTCQLQ30/BN20 results between groups at study end.
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): NCT03475186
|Contact: Karen Craver, MT, MHA||336-716-0891||NCORP@wakehealth.edu|
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|Principal Investigator:||Michael D Chan, MD||Wake Forest University Health Sciences|