Cervical CancerPhase 3NCT00462813
Diindolylmethane in Treating Patients With Abnormal Cervical Cells
A Phase 3 study testing oral microencapsulated diindolylmethane, polymerase chain reaction and cervical Papanicolaou test in people with Cervical Cancer and Precancerous Condition, run by Barts and the London School of Medicine and Dentistry at 2 sites in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Cervical Cancer, Precancerous Condition
- What is being tested?
- oral microencapsulated diindolylmethane, polymerase chain reaction and cervical Papanicolaou test
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 3,000 participants
- Where
- 2 sitesUnited Kingdom
- Study dates
- Oct 2004to Jan 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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)
Trial locations and contacts
2 sites in 1 country.
United Kingdom2 sites
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Barts and the London School of Medicine
London, England, EC1M 6BQ
About this study
Official title: An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]
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.
Read the detailed description
OBJECTIVES:
- Compare the effect of diindolylmethane vs placebo in reducing the prevalence of histologically proven high-grade cervical intraepithelial neoplasia in patients with low-grade cervical cytological abnormalities.
- Compare the effect of these regimens in reducing the prevalence of cytological abnormalities in these patients.
- Compare the effect of these regimens in changing the clinical appearance of the cervix in these patients.
- Determine if diindolylmethane offers benefits in relation to human papillomavirus (HPV) status, including HPV type, viral load, and integration.
- Determine the side effects of supplementation with diindolylmethane.
- Determine the effects of this drug on migraine, mastalgia, weight, and premenstrual syndrome (PMS).
OUTLINE: This is a double-blind, randomized, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral diindolylmethane once daily for 6 months.
- Arm II: Patients receive oral placebo once daily for 6 months. Patients undergo cervical sampling at baseline and at 6 months for Pap testing by liquid based cytology and human papillomavirus (HPV) testing by polymerase chain reaction. Some patients also undergo urine and hair sample collection at baseline and at 3 and 6 months. Samples are analyzed for estrogen and diindolylmethane metabolites, to monitor patient compliance and response to treatment. Some patients have a cervical photograph taken using a colposcope at baseline and at 6 months. All patients undergo colposcopy at 6 months.
Patients complete a questionnaire at baseline (i.e., for reproductive history, diet, smoking, and premenstrual symptoms) and at 6 months (i.e., for side effects, compliance, changes in smoking, and contraception use). Patients with moderate to severe premenstrual syndrome (PMS) also complete PMS questionnaires once monthly during months 1-6 and 4 months following completion of study therapy. All patients are instructed to maintain current diet and to keep cruciferous vegetables and soy products constant during study course.
After completion of study treatment, patients are followed periodically for up to 7 years.
PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study.
- Conditions
- Cervical Cancer, Precancerous Condition
- Being tested
- oral microencapsulated diindolylmethane, polymerase chain reaction, cervical Papanicolaou test, cytology specimen collection procedure, colposcopic biopsy
- Keywords
- cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical intraepithelial neoplasia grade 1
- Medical subject headings
- Uterine Cervical Neoplasms, Precancerous Conditions, Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oral microencapsulated diindolylmethaneDrug
polymerase chain reactionGenetic
cervical Papanicolaou testOther
cytology specimen collection procedureOther
colposcopic biopsyProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months
Secondary outcomes (6)
Change in lesion size at 6 months
Human papillomavirus (HPV) status and characteristics (type, viral load, and integration) at baseline and 6 months
Change in cervical cytology at 6 months
CIN ≥ grade 3 on histology at 6 months
Long term follow-up (i.e., 7 years)
Migraine, premenstrual syndrome (PMS), menstruation, and body weight
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startOct 2004
- Primary completionJun 2008
- Study completionJan 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cervical CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
- Enrolment
- 3,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Barts and the London School of Medicine and Dentistry
- Sponsor type
- University, hospital or other
- Investigators
- Peter Sasieni, MD, Study chair, Barts and the London School of Medicine and Dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462813
- Sponsor's protocol ID
- CRUK-CRISP-1
- Other IDs
- CDR0000539352, ISRCTN47437431, EU-20717
- Status last verified
- Sep 2008
- First submitted
- 18 Apr 2007
- Last updated
- 7 Aug 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Investigation Into the Effects of Diidolylmethane (BioResponse DIM®) Supplementation in Women With Low-Grade Cervical Cytological Abnormalities [CRISP-1]
- ClinicalTrials.gov ID
- NCT00462813
- Acronym / sponsor ID
- CRUK-CRISP-1
- Conditions
- Cervical Cancer, Precancerous Condition
- Keywords
- cervical cancer, cervical intraepithelial neoplasia grade 2, cervical intraepithelial neoplasia grade 3, cervical intraepithelial neoplasia grade 1
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- Barts and the London School of Medicine and DentistryUniversity, hospital or other
- Study start
- Oct 2004
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jan 2010 (actual)
- First posted
- 19 Apr 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
OBJECTIVES:
- Compare the effect of diindolylmethane vs placebo in reducing the prevalence of histologically proven high-grade cervical intraepithelial neoplasia in patients with low-grade cervical cytological abnormalities.
- Compare the effect of these regimens in reducing the prevalence of cytological abnormalities in these patients.
- Compare the effect of these regimens in changing the clinical appearance of the cervix in these patients.
- Determine if diindolylmethane offers benefits in relation to human papillomavirus (HPV) status, including HPV type, viral load, and integration.
- Determine the side effects of supplementation with diindolylmethane.
- Determine the effects of this drug on migraine, mastalgia, weight, and premenstrual syndrome (PMS).
OUTLINE: This is a double-blind, randomized, placebo-controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive oral diindolylmethane once daily for 6 months.
- Arm II: Patients receive oral placebo once daily for 6 months. Patients undergo cervical sampling at baseline and at 6 months for Pap testing by liquid based cytology and human papillomavirus (HPV) testing by polymerase chain reaction. Some patients also undergo urine and hair sample collection at baseline and at 3 and 6 months. Samples are analyzed for estrogen and diindolylmethane metabolites, to monitor patient compliance and response to treatment. Some patients have a cervical photograph taken using a colposcope at baseline and at 6 months. All patients undergo colposcopy at 6 months.
Patients complete a questionnaire at baseline (i.e., for reproductive history, diet, smoking, and premenstrual symptoms) and at 6 months (i.e., for side effects, compliance, changes in smoking, and contraception use). Patients with moderate to severe premenstrual syndrome (PMS) also complete PMS questionnaires once monthly during months 1-6 and 4 months following completion of study therapy. All patients are instructed to maintain current diet and to keep cruciferous vegetables and soy products constant during study course.
After completion of study treatment, patients are followed periodically for up to 7 years.
PROJECTED ACCRUAL: A total of 3,000 patients will be accrued for this study.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Masking
- Double blind
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oral microencapsulated diindolylmethane | Drug | – |
| polymerase chain reaction | Genetic | – |
| cervical Papanicolaou test | Other | – |
| cytology specimen collection procedure | Other | – |
| colposcopic biopsy | Procedure or surgery | – |
Primary outcome
Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months
6 secondary outcomes
Change in lesion size at 6 months
Human papillomavirus (HPV) status and characteristics (type, viral load, and integration) at baseline and 6 months
Change in cervical cytology at 6 months
CIN ≥ grade 3 on histology at 6 months
Long term follow-up (i.e., 7 years)
Migraine, premenstrual syndrome (PMS), menstruation, and body weight
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2013.
- Effect of diindolylmethane supplementation on low-grade cervical cytological abnormalities: double-blind, randomised, controlled trial. Br J Cancer. 2012 Jan 3;106(1):45-52. doi: 10.1038/bjc.2011.496. Epub 2011 Nov 10.Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Sasieni, MD study chair
Barts and the London School of Medicine and Dentistry
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing oral microencapsulated diindolylmethane, polymerase chain reaction and cervical Papanicolaou test in people with Cervical Cancer and Precancerous Condition, run by Barts and the London School of Medicine and Dentistry at 2 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biopsy confirmed high-grade cervical intraepithelial neoplasia (CIN) at 6 months. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2013.