NCT06626230

Safety of Anal Curcumin

An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Lisa Flowers · Academic / Other
• Sex: All
• Age: 30 Years
• Healthy volunteers: Accepted

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 (aHSIL/AIN 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.

Conditions

• Anal High Grade Squamous Intraepithelial Lesion

Interventions

Type	Name	Description
DRUG	Curcuminoid Capsules	500 mg curcuminoids from C3 Complex capsule. Curcuma longa (Turmeric), a constituent of the spice turmeric, is considered a low-toxicity, dietary-derived agent with chemopreventive and therapeutic benefits Study participants will be instructed to insert the curcumin capsules gelatin intra-anally every day for a 14-day treatment period. Escalating doses

Timeline

• Start date: 2025-03-17
• Primary completion: 2026-01-01
• Completion: 2026-01-01
• First posted: 2024-10-03
• Last updated: 2025-04-23

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study