Safety of Anal Curcumin

Launched by LISA FLOWERS · Oct 1, 2024

Keywords

ClinConnect Summary

This clinical trial is investigating the safety of a substance called curcumin, which is found in turmeric, to see if it can help reverse anal high-grade squamous intraepithelial lesions (aHSIL). These are abnormal changes in cells that can lead to anal cancer, especially in people living with HIV. The goal of the study is to find an alternative to current treatments, like surgery or heat treatment, which can have unwanted side effects. The trial is currently looking for participants who are 35 years or older and have been diagnosed with specific types of anal lesions.

If you decide to participate, you'll be asked to keep a diary about your experience during the study. It's important to note that certain health conditions, such as significant heart or lung diseases, may prevent you from joining, and you should not have a history of anal cancer. Additionally, pregnant individuals or those planning to become pregnant in the near future cannot participate. Overall, this trial aims to explore a new option for treating abnormal anal cells safely and effectively.

Gender

ALL

Eligibility 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