Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy

NCT ID: NCT06553157

Last Updated: 2026-01-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-01
• Study Completion Date: 2025-10-01

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.

Detailed Description

Cisplatin and other platinum salt agents, including carboplatin and oxaliplatin, are widely used chemotherapy agents in patients with solid malignancies. These agents remain the backbone of treatment for ovarian, cervical, testicular, non-small-cell lung, bladder, and head and neck cancers. It is estimated that more than 500,000 patients diagnosed with these cancers annually in the United States could be candidates for treatment with cisplatin. However, adverse effects such as ototoxicity, neurotoxicity, and nephrotoxicity can sometimes limit their use. The incidence of ototoxicity induced by cisplatin has been estimated to be 36% of adult patients with cancer and 40%-60% of pediatric patients. Ototoxicity can be vestibular or cochlear toxicity or both, which can manifest as tinnitus (ringing in the ear), ear pain, and frank hearing loss.

The receipt of cisplatin is associated with a 5-fold increase in the risk of hearing impairment, and the incidence and severity are cumulative with exposure. Ototoxicity can manifest as tinnitus, hearing loss in the high-frequency range (4,000 to 8,000 Hz), or at late stages, a decreased ability to hear in the lower-frequency normal conversation range. It can occur during or after treatment and can be unilateral or bilateral affect both ears. Usually, hearing loss can start at higher frequencies in the beginning and can be permanent. In fact, severe ototoxicity with deafness has been reported even after a single cycle of cisplatin. Hence, monitoring and early identification of cisplatin-induced hearing loss are crucial to prevent detrimental impact on hearing and thereby the quality of life (QoL). Children affected by hearing loss have a poorer QoL as evident from their ability to communicate and interact with family and peers, their independence, and emotional well-being.The negative impact of hearing impairment on the patients' health-related QoL including social isolation, anxiety, and depression is well supported by a large body of evidence.

In the literature, two studies were found exploring the effect of statins on the incidence of ototoxicity induced by cisplatin, one retrospective study found that patients who used statins concurrently with their cisplatin chemotherapy had a lower incidence of developing ototoxicity, similar results were proven by a study conducted on mice that found that lovastatin protects against development of ototoxicity resulting from cisplatin therapy , a randomized controlled trial exploring the effect of statins on ototoxicity is needed.

Conditions

Solid Tumors; Ototoxicity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

control group

no intervention

Group Type: NO_INTERVENTION

No interventions assigned to this group

intervention group

study drug once daily for treatment period

Group Type: EXPERIMENTAL

Statin

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

atorvastatin

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Minia University Hospital

OTHER

Sponsor Role: collaborator

Minia University

OTHER

Sponsor Role: lead

Responsible Party

Noha Hassan Mohamed Helmy

Teaching asistant in clinical pharmacy department, Faculty of Pharmacy, Minia university

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Noha H. Helmy, Masters

Role: PRINCIPAL_INVESTIGATOR

Department of Clinical Pharmacy, Faculty of Pharmacy, Minia University

Fatma M. Mady, Professor

Role: STUDY_CHAIR

Pharmaceutics Department, Faculty of Phramacy, Minia university

Nada H. Ali Sholkami, PhD

Role: STUDY_DIRECTOR

Department of Clinical Oncology, Faculty of Medicine, Minia University

Eman M. Sadek, PhD

Role: STUDY_DIRECTOR

Deaprtment of Clinical Pharmacy, Faculty of Pharmacy, Minia university

Dalia F. Mohammed Fahim, PhD

Role: STUDY_DIRECTOR

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

Locations

Minia University hospital, department of oncology and nuclear medicine

Minya, Minya Governorate, Egypt

Countries

Egypt

References

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.

Reference Type: BACKGROUND

PMID: 32062294 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 33393488 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 14570962 (View on PubMed)

Other Identifiers

Statins in ototoxicity

Identifier Type: -

Identifier Source: org_study_id