Testing Ramipril to Prevent Memory Loss in People With Glioblastoma
| Status: | Recruiting |
|---|---|
| Conditions: | Cognitive Studies, Cognitive Studies, Brain Cancer |
| Therapuetic Areas: | Oncology, Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 4/3/2019 |
| Start Date: | March 25, 2019 |
| End Date: | August 2021 |
| Contact: | Karen Craver, MT, MHA |
| Email: | kcraver@wakehealth.edu |
| Phone: | 336-713-4394 |
Pilot Study of Ramipril for Preventing Radiation-Induced Cognitive Decline in Glioblastoma (GBM) Patients Receiving Brain Radiotherapy
This study is to determine if an oral drug called Ramipril can lower the chance of memory
loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during
chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using
several neurocognitive tests throughout the duration of the study.
loss in patients with glioblastoma getting chemoradiation. Patients will take Ramipril during
chemoradiation and continue until 4 months post-treatment. Memory loss will be assessed using
several neurocognitive tests throughout the duration of the study.
This is a pilot study of an oral drug Ramipril to prevent cognitive decline in glioblastoma
patients receiving partial brain radiation and concurrent and adjuvant temozolomide .
Ramipril will be titrated to the highest tolerable dose during chemoradiation (2.5-5 mg).
Once this dose is determined, the patient will continue at this dose for 4 months after the
completion of chemoradiation. Patients will be followed until 5 months post chemoradiation
for compliance, toxicity, cognitive decline and participant reported outcomes (PRO).
patients receiving partial brain radiation and concurrent and adjuvant temozolomide .
Ramipril will be titrated to the highest tolerable dose during chemoradiation (2.5-5 mg).
Once this dose is determined, the patient will continue at this dose for 4 months after the
completion of chemoradiation. Patients will be followed until 5 months post chemoradiation
for compliance, toxicity, cognitive decline and participant reported outcomes (PRO).
Inclusion Criteria:
- Histologically proven diagnosis of glioblastoma or gliosarcoma (WHO grade IV)
- Patient planning to receive brain radiation therapy, and concurrent and adjuvant
temozolomide chemotherapy as per standard of care therapy
- Patient must be able to complete neurocognitive tests in the English language
- Women of childbearing potential and male participants must practice adequate
contraception
Exclusion Criteria:
- Prior allergic reaction or intolerance to angiotensin-converting-enzyme (ACE)
inhibitor
- Current ACE inhibitor or angiotensin receptor blocker use
- Recurrent or multifocal malignant gliomas
- Prior chemotherapy for cancers of the head and neck region
- Prior treatment with temozolomide
- Planning to receive therapeutic antitumor agents in addition to standard radiation and
concurrent and adjuvant temozolomide
- Pregnant or lactating women
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