Clinical trial · Interventional
Topical Curcumin for Precancer Cervical Lesions
Biomolecular Effects of Topical Curcumin in HSIL Cervical Neoplasia
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Study was terminated due to patient feedback and need to redesign the delivery method.
Summary
Brief summary (as posted)
The purpose of this study is to see if curcumin can reverse a cervical precancerous state by looking at people who have the condition and intervening with a study drug or placebo (an inactive drug), prior to planned therapeutic loop electrosurgical excision procedure (LEEP) which is a treatment procedure for removing cervical cancer. 40 women with high grade squamous intraepithelial lesion (HSIL) of the cervix will be enrolled to either insert 2000 mg capsule of curcumin or a placebo in their vagina once a week for 12 weeks. After a 4 week long washout period the participants will then undergo removal of the precancerous cells as recommended standard of care. Participants will have regular monthly visits for the duration of the study.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Curcumin | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Curcumin Arm
- description
- Participants in this arm will use 2000 mg of intravaginal curcumin once a week for 12 weeks.
- interventionNames
- Drug: Curcumin
- type
- PLACEBO_COMPARATOR
- label
- Placebo Arm
- description
- Participants in this arm will use 2000 mg of a placebo once a week for 12 weeks.
- interventionNames
- Drug: Placebo
Primary outcomes (1)
- measure
- Number of Participants With Human Papillomavirus (HPV) Related Molecular Target HPV E6/E7 Messenger Ribonucleic Acid (mRNA) Expression Within HSIL Lesions of the Cervix
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
Inclusion Criteria: * HIV positive women and HIV negative women * HSIL cytology with no invasive features identified on colposcopy or the baseline biopsy * Compliant on combined antiretrovirals (cART) * On continuous antiretrovirals with cluster of differentiation 4 (CD4) count \>200 cells/ml with sustained undetectable viral load for at least 3 months * Patient on reliable birth control. Adequate birth control includes: Combined oral contraceptive pill (OCP), Long Lasting Reversible Contraceptive (LARCP), BiLateral Tubal Ligation (BLT) and DepoProvera Shot/Birth control shot. * Patient willing to conform to the study requirements * No risk factors for microinvasive disease (no colposcopic features of microinvasion, adequate colposcopy and negative endocervical curettage) Exclusion Criteria: * Lactating and pregnant women * Patient with irregular cycles (more than once a month). * Previous hysterectomy and/or prior treatment for cervical precancer condition
References
Publications (0)
Data not yet available