RecruitingPhase 1NCT06626230

Safety of Anal Curcumin

An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin

Sponsor

Lisa Flowers

Enrollment

48 participants

Start Date

Mar 17, 2025

Study Type

INTERVENTIONAL

Conditions

Anal High Grade Squamous Intraepithelial Lesion

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.

Eligibility

Min Age: 30 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether curcumin (a natural compound found in turmeric) applied directly to the anal canal is safe and may help treat abnormal cell changes in the anal lining called anal intraepithelial neoplasia (AIN), which can be a precursor to anal cancer. **You may be eligible if...** - You are 30 years or older - You have biopsy-confirmed AIN 2 or AIN 3 that has not been previously treated, OR you have abnormal anal cytology results (ASC-H or HSIL) - You are willing and able to complete a study diary **You may NOT be eligible if...** - You have a serious progressive chronic illness such as heart failure, severe COPD, or uncontrolled diabetes - You have ever had anal cancer - You are pregnant or planning to become pregnant in the next 3 months Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCurcuminoid 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

Locations(2)

Grady Memorial Hospital

Atlanta, Georgia, United States

Grady Hospital - Ponce De Leon Clinic

Atlanta, Georgia, United States

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NCT06626230

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