Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy
NCT06553157 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 56
Last updated 2026-01-20
Summary
Platinum based chemotherapy (mainly Cisplatin) is known to cause a variety of adverse effects, including Ototoxicity and nephrotoxicity. Ototoxicity is estimated to affect about 36% of adult patients treated with cisplatin, many therapeutic interventions have been studied to reduce the risk of developing ototoxicity from Cisplatin treatment, Statins have been studied in animals and have shown promising results, this study is aimed to explore the effect of statins on the incidence of ototoxicity in humans.
Conditions
- Solid Tumors
- Ototoxicity
Interventions
- DRUG
-
Statin
Statins are drugs known to help lower total cholesterol and reduce the risk of a heart attack or stroke. Statins include atorvastatin , fluvastatin , lovastatin , pitavastatin , pravastatin, rosuvastatin and simvastatin.
Sponsors & Collaborators
-
Minia University Hospital
collaborator OTHER -
Minia University
lead OTHER
Principal Investigators
-
Noha H. Helmy, Masters · Department of Clinical Pharmacy, Faculty of Pharmacy, Minia University
-
Fatma M. Mady, Professor · Pharmaceutics Department, Faculty of Phramacy, Minia university
-
Nada H. Ali Sholkami, PhD · Department of Clinical Oncology, Faculty of Medicine, Minia University
-
Eman M. Sadek, PhD · Deaprtment of Clinical Pharmacy, Faculty of Pharmacy, Minia university
-
Dalia F. Mohammed Fahim, PhD · Department of ENT, Audio-Vestibular Unit, Faculty of Medicine,Minia University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- PREVENTION
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2024-09-01
- Primary Completion
- 2025-07-01
- Completion
- 2025-10-01
Countries
- Egypt
Study Locations
More Related Trials
-
Hearing Loss and Dizziness in Patients Receiving Oxaliplatin for Solid Tumors
NCT00305799 ·Status: COMPLETED
-
Testing the Addition of an Anti-cancer Drug, BAY 1895344, to the Usual Chemotherapy Treatment (Cisplatin, or Cisplatin and Gemcitabine) for Advanced Solid Tumors With Emphasis on Urothelial Cancer
NCT04491942 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE1
-
Platinum in Treating Patients With Residual Triple-Negative Breast Cancer Following Neoadjuvant Chemotherapy
NCT02445391 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE3
-
Gemcitabine and Cisplatin Before or After Surgery in Treating Patients With Stage I or Stage II Non-Small Cell Lung Cancer
NCT00398385 ·Status: UNKNOWN ·Phase: PHASE2
-
Cancer and Hearing Loss Related in Children
NCT02425397 ·Status: COMPLETED
-
Adjuvant Cisplatin Plus Gemcitabine in Operable Cholangiocellular Carcinoma.
NCT01073839 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Cisplatin and Etoposide Prior to Radiation Therapy in Treating Patients With CNS Tumors
NCT00002472 ·Status: COMPLETED ·Phase: PHASE2
-
Docetaxel, Capecitabine, and Cisplatin in Treating Patients With Advanced Solid Tumors
NCT00084734 ·Status: COMPLETED ·Phase: PHASE1
-
Investigation of Cisplatin-Related Kidney Toxicity
NCT00984035 ·Status: COMPLETED
-
Study Comparing Short Infusion Vs. Fixed Dose of Cisplatin + Gemcitabine in Non Small Cell Lung Cancer.
NCT00191620 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine, Cisplatin, and Gefitinib in Treating Patients Who Are Undergoing Surgery for Stage III Non-Small Cell Lung Cancer
NCT00103051 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine and Cisplatin in Treating Patients With Metastatic Breast Cancer
NCT00002998 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine and Cisplatin Without Cystectomy for Patients With Muscle Invasive Bladder Urothelial Cancer and Select Genetic Alterations
NCT03609216 ·Status: ACTIVE_NOT_RECRUITING ·Phase: PHASE2
-
Gemcitabine and Cisplatin for Advanced or Recurrent Endometrial Cancer
NCT00388154 ·Status: COMPLETED ·Phase: PHASE2
-
Combination Chemotherapy in Treating Patients With Solid Tumors
NCT00009932 ·Status: UNKNOWN ·Phase: PHASE1
-
Safety, Tolerability and Pharmacokinetics of Quisinostat, a Histone Deacetylase Inhibitor, in Combination With Chemotherapy
NCT02728492 ·Status: COMPLETED ·Phase: PHASE1
-
Gemcitabine and Cisplatin as First Line Combination Therapy in Patients With Triple-negative MBC
NCT00601159 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1 Study of PI3 (Phosphatidylinositol-3)-Kinase Inhibitor Copanlisib With Gemcitabine or Cisplatin Plus Gemcitabine in Patients With Advanced Cancer
NCT01460537 ·Status: COMPLETED ·Phase: PHASE1
-
Combination Chemotherapy for Metastatic Breast Cancer
NCT00191815 ·Status: COMPLETED ·Phase: PHASE2
-
Gemcitabine in Combination With Cisplatin as Neoadjuvant NSCLC Chemotherapy
NCT00191841 ·Status: COMPLETED ·Phase: PHASE2
-
Safety and Tolerability Study of Farnesyl Protein Transferase Inhibitor in Combination With Gemcitabine and Cisplatin in Advanced Cancer (Study P01499)(TERMINATED)
NCT00040534 ·Status: TERMINATED ·Phase: PHASE1
-
Clarify of Predictive Risk Factors of Chemotherapy-induced Liver Injury
NCT03069820 ·Status: UNKNOWN ·Phase: PHASE4
-
Evaluation of the Effect of Genetic Polymorphisms in ERCC1 and OCT2 on the Occurrence and Severity of Cisplatin-induced Nephrotoxicity
NCT05247671 ·Status: UNKNOWN
-
Trial of Perioperative Chemotherapy (Gemcitabine and Cisplatin) and Adjuvant Chemoradiotherapy (With Weekly Low Dose Gemcitabine) in Patients With Lung Cancer With Positive Nodes
NCT00490659 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I Combination Ixabepilone + Cisplatin
NCT00832117 ·Status: COMPLETED ·Phase: PHASE1