Clinical trial · Interventional
Diindolylmethane in Treating Patients With Abnormal Cervical Cells
An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming. The use of diindolylmethane, a substance found in cruciferous vegetables, may keep cervical intraepithelial neoplasia or cervical cancer from forming. PURPOSE: This randomized phase III trial is studying diindolylmethane to see how well it works compared to a placebo in treating patients with abnormal cervical cells.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
| Precancerous Condition | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| cervical Papanicolaou test | Other | — | UNRESOLVED |
| colposcopic biopsy | Procedure | — | UNRESOLVED |
| cytology specimen collection procedure | Other | — | UNRESOLVED |
| oral microencapsulated diindolylmethane | Drug | — | UNRESOLVED |
| polymerase chain reaction | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months
Secondary outcomes (6)
- measure
- Change in lesion size at 6 months
- measure
- Human papillomavirus (HPV) status and characteristics (type, viral load, and integration) at baseline and 6 months
- measure
- Change in cervical cytology at 6 months
- measure
- CIN ≥ grade 3 on histology at 6 months
- measure
- Long term follow-up (i.e., 7 years)
- measure
- Migraine, premenstrual syndrome (PMS), menstruation, and body weight
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
DISEASE CHARACTERISTICS: * First mildly dyskaryotic Pap smear or a second borderline Pap smear taken within the Cervical Screening Wales program * Patients under surveillance following treatment for high-grade cervical intraepithelial neoplasia are not eligible * No clinical suspicion of a concurrent invasive cervical cancer PATIENT CHARACTERISTICS: * No invasive cancer within the past 3 years * No known HIV positivity * Not pregnant or nursing * Not planning to become pregnant within the next 6 months PRIOR CONCURRENT THERAPY: * No concurrent immunosuppressive drugs, warfarin, or theophylline * No concurrent proton pump inhibitor drugs for ulcer or reflux disease (i.e., rabeprazole, esomeprazole magnesium, lansoprazole, omeprazole, or pantoprazole sodium)
References
Publications (0)
Data not yet available