RecruitingPhase 1

Safety of Anal Curcumin

United States48 participantsStarted 2025-03-17

Plain-language 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.

Who can participate

Age range

30 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Major Inclusion Criteria: * 30 and older * Have biopsy-proven anal intraepithelial neoplasia (AIN) 2, AIN 3 without previous treatment * Or cytology results for ASC-H or HSIL * Able and willing to complete Study Diary * Other inclusion criteria apply Exclusion Criteria: * Have a clinically significant chronic medical condition that is considered progressive, such as but not limited to coronary disease, congestive heart failure, chronic obstructive lung disease, and diabetes mellitus. Chronic nonprogressive or intermittent syndromes are not excluded, including migraine headaches, mild reactive airway disease, controlled hypertension, stable pain syndromes, or benign gastric reflux. * Have any history of anal cancer malignancy. * Pregnant or planning to become pregnant in the next three months. * Have a history of sensitivity or allergy to any compound used in this study. * Have Grade 2 or higher renal or hematology abnormality, * Are currently using, or in the last year have used intravenous drugs (except for therapeutic use), recreational drugs, or alcohol abuse. * Other exclusion criteria apply

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Maximum curcumin tolerated dose

Timeframe: Up to 22 days after treatment

Trial details

NCT IDNCT06626230

SponsorLisa Flowers

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-07

Contact for this trial

Lisa Flowers, MD, MPH

404-251-8931 lflowe2@emory.edu

View on ClinicalTrials.gov More Anal High Grade Squamous Intraepithelial Lesion trials