Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553157
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-10
Brief Title:
Statins Effect on Incidence of Side Effects of Platinum Based Chemotherapy
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Evaluation of the Effect of Statins on the Incidence of Side Effects of Platinum Based Chemotherapy in Patients With Solid Tumors
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 500000 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 4000 to 8000 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-beingThe 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
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 4000 to 8000 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-beingThe 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None