Safety of Anal Curcumin

Lisa Flowers

Status and phase: Enrolling; Phase 1

Conditions: Anal High Grade Squamous Intraepithelial Lesion

Treatments: Drug: Curcuminoid Capsules

Study type: Interventional

Funder types: Other

Identifiers

NCT06626230

STUDY00007193

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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48 participants in 8 patient groups

Dose Level 1

Experimental group

Description:

Participants will receive a supply of curcumin gelatin capsules to insert 500 mg intra-anally every day for a 14-day treatment period

Treatment:

Drug: Curcuminoid Capsules

Dose Level 2

Experimental group

Description:

Participants will receive a supply of curcumin gelatin capsules to insert 1000 mg intra-anally every day for a 14-day treatment period

Treatment:

Drug: Curcuminoid Capsules

Dose Level 3

Experimental group

Description:

Participants will receive a supply of curcumin gelatin capsules to insert 1500 mg intra-anally every day for a 14-day treatment period

Treatment:

Drug: Curcuminoid Capsules

Dose Level 4

Experimental group

Description:

Participants will receive a supply of curcumin gelatin capsules to insert 2000 mg intra-anally every day for a 14-day treatment period

Treatment:

Drug: Curcuminoid Capsules

Dose Level 5

Experimental group

Description:

Participants will receive a supply of curcumin gelatin capsules to insert 2500 mg intra-anally every day for a 14-day treatment period

Treatment:

Drug: Curcuminoid Capsules

Dose Level 6

Experimental group

Description:

Participants will receive a supply of curcumin gelatin capsules to insert 3000 mg intra-anally every day for a 14-day treatment period

Treatment:

Drug: Curcuminoid Capsules

Dose Level 7

Experimental group

Description:

Participants will receive a supply of curcumin gelatin capsules to insert 3500 mg intra-anally every day for a 14-day treatment period

Treatment:

Drug: Curcuminoid Capsules

Dose Level 8

Experimental group

Description:

Participants will receive a supply of curcumin gelatin capsules to insert 4000 mg intra-anally every day for a 14-day treatment period

Treatment:

Drug: Curcuminoid Capsules