Ignite Creation Date:
2024-10-26 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 3:41 PM
Study NCT ID:
NCT06626230
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-10-01
Brief Title:
Safety of Anal Curcumin
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
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:
The purpose of this study is to see if curcumin can reverse anal high-grade squamous intraepithelial lesions aHSIL high-grade anal precancerous cells or high-grade abnormal cells in people living with HIV to avoid current treatments such as ablation destroying abnormal cells with heat or surgical excision cutting out the abnormal cells which have potential short- and long-term side effects
Detailed Description:
This proposal suggests conducting a Phase I clinical trial using a 3 3 dose escalation approach to assess the safety and determine the maximum tolerated dose of intra-anal curcumin in individuals with HIV who have anal high-grade squamous intraepithelial lesions aHSILAIN 2-3 Currently there is a significant need for non-surgical treatments for pre-malignant anal diseases in people with HIV aiming to reduce risks and complications associated with existing surgical and topical interventions
Curcumin a compound derived from turmeric is known for its anti-inflammatory and anti-infectious properties While previous research has shown its anticancer effects in oral doses its bioavailability is limited and intra-anal administration has not been studied in humans This trial aims to explore the potential of intra-anal curcumin as an alternative treatment for aHSIL in people with HIV
The study will involve enrolling participants with aHSIL and administering increasing doses of curcumin intra-anally for 14 days following the 3 3 dose escalation model The trial will continue until the dose-limiting toxicity DLT level is reached and participants report symptoms necessitating a dose reduction
To enhance future studies the researchers will also evaluate patient and male partner acceptability through questionnaires The insights gained from this trial will guide the design of subsequent efficacy and safety studies for individuals with AIN 2 and 3 neoplasia
Curcumin a compound derived from turmeric is known for its anti-inflammatory and anti-infectious properties While previous research has shown its anticancer effects in oral doses its bioavailability is limited and intra-anal administration has not been studied in humans This trial aims to explore the potential of intra-anal curcumin as an alternative treatment for aHSIL in people with HIV
The study will involve enrolling participants with aHSIL and administering increasing doses of curcumin intra-anally for 14 days following the 3 3 dose escalation model The trial will continue until the dose-limiting toxicity DLT level is reached and participants report symptoms necessitating a dose reduction
To enhance future studies the researchers will also evaluate patient and male partner acceptability through questionnaires The insights gained from this trial will guide the design of subsequent efficacy and safety studies for individuals with AIN 2 and 3 neoplasia
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