RECRUITING

Safety of Anal Curcumin

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

An Incremental Dose Escalation Trial of Safety and Tolerability of Curcumin

Quick Facts

Study Start:2025-02
Study Completion:2026-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06626230

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.

Ages Eligible for Study:35 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 35 and older
  2. * Have biopsy-proven anal intraepithelial neoplasia (AIN) 2 and AIN 3 within 4 months of enrollment.
  3. * Able and willing to complete Study Diary
  4. * Other inclusion criteria apply
  1. * 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.
  2. * Have any history of anal cancer malignancy.
  3. * Pregnant or planning to become pregnant in the next three months.
  4. * Have a history of sensitivity or allergy to any compound used in this study.
  5. * Have Grade 2 or higher renal or hematology abnormality,
  6. * Are currently using, or in the last year have used intravenous drugs (except for therapeutic use), recreational drugs, or alcohol abuse.
  7. * Other exclusion criteria apply

Contacts and Locations

Study Contact

Lisa Flowers, MD, MPH
CONTACT
404-251-8931
lflowe2@emory.edu

Principal Investigator

Lisa Flowers, MD, MPH
PRINCIPAL_INVESTIGATOR
Emory University

Study Locations (Sites)

Grady Memorial Hospital
Atlanta, Georgia, 30303
United States
Grady Hospital - Ponce De Leon Clinic
Atlanta, Georgia, 30308
United States

Collaborators and Investigators

Sponsor: Lisa Flowers

  • Lisa Flowers, MD, MPH, PRINCIPAL_INVESTIGATOR, 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 Registration Dates

Study Start Date2025-02
Study Completion Date2026-01

Study Record Updates

Study Start Date2025-02
Study Completion Date2026-01

Terms related to this study

Keywords Provided by Researchers

  • HSIL/AIN 2-3
  • Curcumin
  • Cancer
  • Human Papillomavirus (HPV)
  • HIV

Additional Relevant MeSH Terms

  • Anal High Grade Squamous Intraepithelial Lesion