A Phase 1/2 interventional study of Statin in Solid Tumors and Ototoxicity, sponsored by Minia University. Completed at 1 site in Egypt. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Minia University · Phase 1/2, Interventional, and Prevention
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.
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.
49 studies on the registry are indexed under Ototoxicity; 15 are open to participants now.
This study's enrollment of 56 is above the median of 47 across 33 interventional studies indexed under Ototoxicity.
Browse Ototoxicity studies →Minia University is the lead sponsor of 370 studies on the registry; 117 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
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ECOG performance status
A scale of how much an illness limits everyday activity. For people being assessed to join a study, scores run from 0 (fully active) to 4; lower is more active.
Studies most often ask for 0–1 or 0–2. Your doctor gives the score; the WHO scale uses the same steps. The full scale also has 5, which records death.
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Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
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no intervention
study drug once daily for treatment period
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.
Also known as: atorvastatin
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
Time frame: 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)
Time frame: 3 months after end of treatment
Plan to share: No
Ran from Sep 2024 to primary completion in Jul 2025, 10 months.
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This study is completed, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Statins