Safety of Anal Curcumin
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age30+
SponsorLisa Flowers
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Sequential
Treatments tested in this trial
Curcuminoid Capsules
Drug500 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
Treatment groups
48 Participants
are divided into 8 treatment groups8
Treatment groupsSee each treatment group below.
Group A: Dose Level 1Experimental treatment 1 intervention
Group B: Dose Level 2Experimental treatment 1 intervention
Group C: Dose Level 3Experimental treatment 1 intervention
Group D: Dose Level 4Experimental treatment 1 intervention
Group E: Dose Level 5Experimental treatment 1 intervention
Group F: Dose Level 6Experimental treatment 1 intervention
Group G: Dose Level 7Experimental treatment 1 intervention
Group H: Dose Level 8Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Maximum curcumin tolerated dose
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.
Time frame
Up to 22 days after treatmentSecondary outcomes
1
Toxicity related to 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.
Time frame
Up to 22 days after treatment2
Anoscopy changes
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)
Time frame
22 days after treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Lisa Flowers
Lead sponsor
Emory University
Sponsor institution
Source ClinicalTrials.gov