Nitazoxanide in Patients With Metastatic Colorectal Cancer
NCT ID: NCT06049901
Last Updated: 2023-09-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
60 participants
INTERVENTIONAL
2023-03-01
2026-03-31
Brief Summary
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Detailed Description
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Nitazoxanide (NTZ) is considered a broad-spectrum anti-microbial drug with a potent activity against various helminths, anaerobic bacteria and viruses. NTZ inhibited the proliferation of CRC cell lines at or below concentrations that normally exhibit anti-parasitic activity.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Control Group
This group will include 30 patients who will be scheduled to receive 6 cycles of 5-Fluorouracil and Oxaliplatin- based regimens every 2 weeks for 3 months.
No interventions assigned to this group
Nitazoxanide Group
This group will include 30 patients who will be scheduled to receive 6 cycles of 5-Fluorouracil and Oxaliplatin- based regimens every 2 weeks plus nitazoxanide (500 mg orally twice daily) for 3 months.
Nitazoxanide
Nitazoxanide is considered a broad-spectrum anti-microbial drug with a potent activity against various helminths, anaerobic bacteria and viruses.
Interventions
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Nitazoxanide
Nitazoxanide is considered a broad-spectrum anti-microbial drug with a potent activity against various helminths, anaerobic bacteria and viruses.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Male or female patients with age range from 18-65 years old
3. Women of childbearing age will be required to be on acceptable forms of contraception
4. No contraindication to chemotherapy (absence of myelosuppression)
5. Performance status \< 2 according to the Eastern Cooperative Oncology Group (ECOG) score
6. Adequate liver function (alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \< grade 2) according to the National Cancer Institute-Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v 5.0)
7. Adequate renal function (estimated creatinine clearance (eCrCl), serum creatinine (SCr) \< grade 2) according to NCI-CTCAE, v 5.0
8. Adequate hematological parameters (hemoglobin, erythrocytes, platelets, leukocytes and absolute neutrophil count (ANC) \< grade 2 according to NCI-CTCAE, v 5.0
Exclusion Criteria
2. Patients who have known allergy to nitazoxanide or its metabolites
3. Patients with concurrent active cancer originating from a primary site other than the colon or rectum
4. Patients who are receiving highly plasma protein-bound drugs or drugs with extensive hepatic metabolism such as; coumarin anti-coagulants, oral hypoglycemic drugs and anti-epileptic drugs
18 Years
65 Years
ALL
No
Sponsors
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Tanta University
OTHER
Responsible Party
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Reham Ameen El-Ghoneimy
Assistant Lecturer of Clinical Pharmacy, Faculty of Pharmacy, Tanta University
Locations
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Tanta University Hospital
Tanta, El-Gharbia Governorate, Egypt
Countries
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Central Contacts
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References
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Biller LH, Schrag D. Diagnosis and Treatment of Metastatic Colorectal Cancer: A Review. JAMA. 2021 Feb 16;325(7):669-685. doi: 10.1001/jama.2021.0106.
Ripani P, Delp J, Bode K, Delgado ME, Dietrich L, Betzler VM, Yan N, von Scheven G, Mayer TU, Leist M, Brunner T. Thiazolides promote G1 cell cycle arrest in colorectal cancer cells by targeting the mitochondrial respiratory chain. Oncogene. 2020 Mar;39(11):2345-2357. doi: 10.1038/s41388-019-1142-6. Epub 2019 Dec 16.
Shakya A, Bhat HR, Ghosh SK. Update on Nitazoxanide: A Multifunctional Chemotherapeutic Agent. Curr Drug Discov Technol. 2018;15(3):201-213. doi: 10.2174/1570163814666170727130003.
Other Identifiers
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Nitazoxanide in mCRC
Identifier Type: -
Identifier Source: org_study_id
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