Curcumin for Precancerous Anal Cells
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests whether curcumin, a natural compound, can reverse precancerous anal cells in people with HIV. The goal is to find a gentler treatment for these cells, avoiding more invasive options like surgery. Participants will use different doses of curcumin capsules inserted anally for two weeks. Those diagnosed with anal intraepithelial neoplasia (AIN) 2 or 3 who have not yet received treatment might be suitable for this trial. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the chance to be among the first to receive this innovative approach.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
Is there any evidence suggesting that this trial's treatment is likely to be safe?
Research has shown that curcumin is generally safe for people. Studies have tested doses as high as 12 grams per day for up to three months without major safety issues. Curcumin is usually well-tolerated, with only mild side effects such as stomach upset or diarrhea reported in some cases. This suggests it is likely safe for shorter periods and lower doses, like those tested in this trial.12345
Why are researchers excited about this trial's treatment?
Unlike the standard treatments for precancerous anal conditions, which often involve topical chemotherapies or surgical interventions, curcumin offers a novel approach by using a natural compound commonly found in turmeric. Researchers are excited about curcumin because it has anti-inflammatory and antioxidant properties, which may help prevent the progression of precancerous cells. Additionally, this treatment is unique because it is administered intra-anally through gelatin capsules, potentially providing direct localized action with reduced systemic side effects. This innovative delivery method could offer a more targeted and less invasive option compared to traditional approaches.
What evidence suggests that curcumin might be an effective treatment for anal precancerous cells?
Research has shown that curcumin might help treat early signs of cancer. Studies have found that curcumin can reduce the number and size of polyps, small growths that can turn into cancer, within three months. Curcumin has also shown potential benefits against various cancers, such as colorectal, pancreatic, and breast cancer. This suggests it might help protect cells from becoming cancerous. In this trial, participants will receive different doses of curcumin to evaluate its potential to manage or reverse high-grade anal precancerous cells (aHSIL) and possibly prevent them from turning into cancer.23567
Who Is on the Research Team?
Lisa Flowers, MD, MPH
Principal Investigator
Emory University
Are You a Good Fit for This Trial?
This trial is for individuals with HIV who have high-grade squamous intraepithelial lesions (aHSIL) in the anal area, which are precancerous cells. The study aims to help those seeking alternatives to current treatments like ablation or surgery that come with side effects.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive increasing doses of curcumin intra-anally for 14 days following a 3 + 3 dose escalation model
Follow-up
Participants are monitored for safety and effectiveness after treatment, including toxicity and anoscopy changes
What Are the Treatments Tested in This Trial?
Interventions
- Curcumin
Curcumin is already approved in United States, European Union, India, China for the following indications:
- Dietary Supplement
- Herbal Medicinal Product
- Traditional Medicine
- Traditional Chinese Medicine
Find a Clinic Near You
Who Is Running the Clinical Trial?
Lisa Flowers
Lead Sponsor