Efficacy of Memantine in Prevention of Oxaliplatin-induced Peripheral Neurotoxicity
Sponsor
Mansoura University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05834231
Collaborator
(none)
60
2
14
Study Details
Study Description
Brief Summary
Memantine is a drug for the management of Alzheimer's Disease (AD) due to its promising neuroprotective properties. We hypothesize that Memantine possesses a beneficial role against chemotherapy-induced neuronal damages.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Efficacy of Memantine in Prevention of Oxaliplatin-induced Peripheral Neurotoxicity
Anticipated Study Start Date
:
Aug 1, 2023
Anticipated Primary Completion Date
:
Mar 1, 2024
Anticipated Study Completion Date
:
Oct 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Intervention
|
Drug: Memantine
oral
|
| Placebo Comparator: Control
|
Drug: Placebo
oral
|
Outcome Measures
Primary Outcome Measures
- Incidence of chemotherapy induced-peripheral neuropathy using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) criteria [6 months]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
histologically confirmed diagnosis of stage III colorectal cancer performance status < 2 according to Eastern Cooperative Oncology Group (ECOG) score adequate renal function (glomerular filtration rate ≥ 90)
Exclusion Criteria:
preexisting neuropathic or brain disorders, a previous use of chemotherapeutic agents including oxaliplatin use of drugs reported to have neuroprotective role
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Mansoura University
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Noha Mansour,
Lecturer of Clinical Pharmacy,
Mansoura University
ClinicalTrials.gov Identifier:
NCT05834231
Other Study ID Numbers:
- 2023
First Posted:
Apr 28, 2023
Last Update Posted:
Apr 28, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: