Safety of Anal Curcumin

August 17, 2026 updated by: Lisa Flowers

An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

48

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Grady Memorial Hospital
      • Atlanta, Georgia, United States, 30308
        • Recruiting
        • Grady Hospital - Ponce De Leon Clinic
        • Principal Investigator:
          • Lisa Flowers, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Level 1
Participants will receive a supply of curcumin gelatin capsules to insert 500 mg intra-anally every day for a 14-day treatment period
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

Other Names:
  • Curcumin C3 Complex
  • Curcuma longa (Turmeric)
Experimental: Dose Level 2
Participants will receive a supply of curcumin gelatin capsules to insert 1000 mg intra-anally every day for a 14-day treatment period
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

Other Names:
  • Curcumin C3 Complex
  • Curcuma longa (Turmeric)
Experimental: Dose Level 3
Participants will receive a supply of curcumin gelatin capsules to insert 1500 mg intra-anally every day for a 14-day treatment period
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

Other Names:
  • Curcumin C3 Complex
  • Curcuma longa (Turmeric)
Experimental: Dose Level 4
Participants will receive a supply of curcumin gelatin capsules to insert 2000 mg intra-anally every day for a 14-day treatment period
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

Other Names:
  • Curcumin C3 Complex
  • Curcuma longa (Turmeric)
Experimental: Dose Level 5
Participants will receive a supply of curcumin gelatin capsules to insert 2500 mg intra-anally every day for a 14-day treatment period
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

Other Names:
  • Curcumin C3 Complex
  • Curcuma longa (Turmeric)
Experimental: Dose Level 6
Participants will receive a supply of curcumin gelatin capsules to insert 3000 mg intra-anally every day for a 14-day treatment period
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

Other Names:
  • Curcumin C3 Complex
  • Curcuma longa (Turmeric)
Experimental: Dose Level 7
Participants will receive a supply of curcumin gelatin capsules to insert 3500 mg intra-anally every day for a 14-day treatment period
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

Other Names:
  • Curcumin C3 Complex
  • Curcuma longa (Turmeric)
Experimental: Dose Level 8
Participants will receive a supply of curcumin gelatin capsules to insert 4000 mg intra-anally every day for a 14-day treatment period
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

Other Names:
  • Curcumin C3 Complex
  • Curcuma longa (Turmeric)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum curcumin tolerated dose
Time Frame: Up to 22 days after treatment
To determine the maximum tolerated dose (MTD) of curcumin, toxicities will be tabulated and reported per dose level according to grade and type of toxicity experienced. The dose level at which no more than 33% of study participants have a DLT will be considered the maximum tolerated dose.
Up to 22 days after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Toxicity related to treatment
Time Frame: Up to 22 days after treatment
Toxicities will be tabulated and reported per dose level according to grade and type of toxicity experienced (tolerability of curcumin). Participants will be monitored during the trial for adverse events, tolerability, and compliance using the Common Terminology Criteria for Adverse Events (CTCAE). Side effects will be recorded in a study diary maintained by the participant.
Up to 22 days after treatment
Anoscopy changes
Time Frame: 22 days after treatment
Participants will receive an anoscopy to examine the anus and perineum for any findings outlined in the anoscopic findings chart (Safety of curcumin intra-anal powder)
22 days after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lisa Flowers

Investigators

  • Principal Investigator: Lisa Flowers, MD, MPH, Emory University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 17, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

August 18, 2026

Last Update Submitted That Met QC Criteria

August 17, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007193
  • 2025P011055 (Other Identifier: Emory Insight Humans IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified Individual participant data that underlie the published results will be made available for sharing.

IPD Sharing Time Frame

Data will be available from December 2025 to January 2031.

IPD Sharing Access Criteria

Data will be available for sharing with researchers providing a methodologically sound proposal, to achieve aims in the approved proposal. Proposals should be directed to lflowe2@emory.edu. The data requestor needs to sign a data access agreement to gain access.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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