Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy

NCT06553157 | Completed Phase 1

• 1 other identifier: Statins in ototoxicity
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

platinum based chemotherapy; Cisplatin; adverse effects; ototoxicity; statins

Outcome Measures

Primary Outcomes (2)

• change in hearing as defined by the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) using Audiometry as a tool

  grade 1:Adults enrolled on a Monitoring Program (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift of 15 - 25 dB averaged at 2 contiguous test frequencies in at least one ear. grade 2: enrolled on a Monitoring Program (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift of \>25 dB averaged at 2 contiguous test frequencies in at least one ear. grade 3: enrolled on a Monitoring Program (on a 1, 2, 3, 4, 6, and 8 kHz audiogram): Threshold shift of \>25 dB averaged at 3 contiguous test frequencies in at least one ear; therapeutic intervention indicated. grade 4: Decrease in hearing to profound bilateral loss (absolute threshold \>80 dB HL at 2 kHz and above); nonservicable hearing

  3 months after end of treatment

• adapted version of the Speech, Spatial and Qualities of Hearing Scale 12 (SSQ12)

  adapted version of the Speech, Spatial and Qualities of Hearing Scale 12 (SSQ12)

  3 months after end of treatment

Study Arms (2)

control group

NO INTERVENTION

no intervention

intervention group

EXPERIMENTAL

study drug once daily for treatment period

Drug: Statin

Interventions

Statin DRUG

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.

Also known as: atorvastatin

intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will receive platinum based chemotherapy.
• Eastern Cooperative Oncology Group (ECOG) performance status from 0 to 2.

You may not qualify if:

• Pregnant or lactating women.
• Patients receiving vitamin/ supplementation drugs that interfere with the study intervention.
• Patients with contraindications to statins including acute liver failure or decompensated cirrhosis.

Sponsors & Collaborators

• Minia University: lead
• Minia University Hospital: collaborator

Study Sites (1)

Minia University hospital, department of oncology and nuclear medicine

Minya, Minya Governorate, 61519, Egypt

Location

Related Publications (3)

• Fernandez K, Spielbauer KK, Rusheen A, Wang L, Baker TG, Eyles S, Cunningham LL. Lovastatin protects against cisplatin-induced hearing loss in mice. Hear Res. 2020 Apr;389:107905. doi: 10.1016/j.heares.2020.107905. Epub 2020 Feb 6.

  PMID: 32062294 BACKGROUND

• Fernandez KA, Allen P, Campbell M, Page B, Townes T, Li CM, Cheng H, Garrett J, Mulquin M, Clements A, Mulford D, Ortiz C, Brewer C, Dubno JR, Newlands S, Schmitt NC, Cunningham LL. Atorvastatin is associated with reduced cisplatin-induced hearing loss. J Clin Invest. 2021 Jan 4;131(1):e142616. doi: 10.1172/JCI142616.

  PMID: 33393488 BACKGROUND

• Dalton DS, Cruickshanks KJ, Klein BE, Klein R, Wiley TL, Nondahl DM. The impact of hearing loss on quality of life in older adults. Gerontologist. 2003 Oct;43(5):661-8. doi: 10.1093/geront/43.5.661.

  PMID: 14570962 BACKGROUND

MeSH Terms

Conditions

Ototoxicity

Interventions

Hydroxymethylglutaryl-CoA Reductase Inhibitors; Atorvastatin

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Anticholesteremic Agents; Hypolipidemic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Enzyme Inhibitors; Lipid Regulating Agents; Therapeutic Uses; Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Study Officials

• Noha H. Helmy, Masters

  Department of Clinical Pharmacy, Faculty of Pharmacy, Minia University

  PRINCIPAL INVESTIGATOR

• Fatma M. Mady, Professor

  Pharmaceutics Department, Faculty of Phramacy, Minia university

  STUDY CHAIR

• Nada H. Ali Sholkami, PhD

  Department of Clinical Oncology, Faculty of Medicine, Minia University

  STUDY DIRECTOR

• Eman M. Sadek, PhD

  Deaprtment of Clinical Pharmacy, Faculty of Pharmacy, Minia university

  STUDY DIRECTOR

• Dalia F. Mohammed Fahim, PhD

  Department of ENT, Audio-Vestibular Unit, Faculty of Medicine,Minia University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching asistant in clinical pharmacy department, Faculty of Pharmacy, Minia university

Study Record Dates

• First Submitted: August 10, 2024
• First Posted: August 14, 2024
• Study Start: September 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: October 1, 2025
• Last Updated: January 20, 2026

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)