Cervical DysplasiaPhase 3NCT00212381
Oral Diindolylmethane (DIM) for the Treatment of Cervical Dysplasia
A Phase 3 study testing di indolylmethane (DIM) and Red rice bran in people with Cervical Dysplasia, run by New York Presbyterian Hospital at 1 site in United States.
Trial summary
To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Cervical Dysplasia
- What is being tested?
- di indolylmethane (DIM) and Red rice bran
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2000to Jul 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 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Non pregnant women greater than or equal to 18 years of age able to consent
- CIN II or III confirmed by histology
- Karnofsky performance status >= 80
- No prior treatment for dysplasia in the past 4 months
Who cannot join
- Incompletely visible lesion
- Diethylstilbestrol (DES) exposure
- HIV seropositive
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)
To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women.
Read the detailed description
To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable based dietary supplement (BioResponse-DIM®), is associated with the regression of cervical dysplasia in otherwise healthy women. Additionally, the study aims to see how the use of the BioResponse-DIM supplement correlates with cervical HPV colonization, and to asses the tolerability of daily DIM supplementation
- Conditions
- Cervical Dysplasia
- Being tested
- di indolylmethane (DIM), Red rice bran
- Keywords
- cervical dysplasia, diindolylmethane, pap smear
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
di indolylmethane (DIM)Drug
This is the agent being studies. Similar agents have been reported to have potential activity.
Red rice branDietary supplement
this will act as the active comparator. The sponsor provided this as the "placebo" arm since it is a filler component of their DIM capsules
| Study group | Role | What they receive |
|---|---|---|
| oral DIM (Active agent) | Experimental | 2mg/kg/day po of DIM Receives: Drug: di indolylmethane (DIM) |
| Red rice bran (Placebo) | Active comparator | this agent is not generally thought to be active but may be Receives: Dietary Supplement: Red rice bran |
What is being measured
The primary outcome is the main question the study is designed to answer.
Measure the regression of CIN in women by cytology, colposcopy, and biopsy,
To determine if oral DIM is effective in promoting the regression of CIN in women
Measured: 3 months
Secondary outcomes (2)
HPV colonization by commercial ELIZA test
To correlate the response to DIM with HPV colonization
Measured: 3 months
Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20
To assess for any adverse effects of oral DIM in women
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2005 (estimated)
- Study startSep 2000
- Primary completionJan 2006
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cervical DysplasiaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- randomized double blind intervention trial
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New York Presbyterian Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Giuseppe Del Priore, New York Presbyterian Hospital
- Investigators
- Giuseppe Del Priore, M.D., M.P.H., Study director, NY Downtown HospitalAlan Arslan, M.D., Principal investigator, NYU School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00212381
- Sponsor's protocol ID
- 9218
- Status last verified
- Mar 2017
- First submitted
- 13 Sep 2005
- Last updated
- 29 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Del Priore G, Gudipudi DK, Montemarano N, Restivo AM, Malanowska-Stega J, Arslan AA. Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia. Gynecol Oncol. 2010 Mar;116(3):464-7. doi: 10.1016/j.ygyno.2009.10.060. Epub 2009 Nov 24.
PubMed 19939441
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Diindolylmethane (DIM) Dietary Supplementation: A Nonsurgical Treatment for Cervical Intraepithelial Neoplasia (CIN)
- ClinicalTrials.gov ID
- NCT00212381
- Acronym / sponsor ID
- 9218
- Conditions
- Cervical Dysplasia
- Keywords
- cervical dysplasia, diindolylmethane, pap smear
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- New York Presbyterian HospitalUniversity, hospital or other
- Study start
- Sep 2000
- Primary completion
- Jan 2006 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 21 Sep 2005 (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.
To determine if the use of oral Diindolylmethante (DIM), a marketed cruciferous vegetable based dietary supplement (Bioresponse-DIM), is associated with the regression of cervical dysplasia in otherwise healthy women.
Detailed description
To determine if the use of oral Diindolylmethane (DIM), a marketed cruciferous vegetable based dietary supplement (BioResponse-DIM®), is associated with the regression of cervical dysplasia in otherwise healthy women. Additionally, the study aims to see how the use of the BioResponse-DIM supplement correlates with cervical HPV colonization, and to asses the tolerability of daily DIM supplementation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- randomized double blind intervention trial
| Arm | Type | Receives |
|---|---|---|
| oral DIM (Active agent) | Experimental | Drug: di indolylmethane (DIM)2mg/kg/day po of DIM |
| Red rice bran (Placebo) | Active comparator | Dietary Supplement: Red rice branthis agent is not generally thought to be active but may be |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Non pregnant women greater than or equal to 18 years of age able to consent
- CIN II or III confirmed by histology
- Karnofsky performance status >= 80
- No prior treatment for dysplasia in the past 4 months
Key exclusion criteria (3 listed)
- Incompletely visible lesion
- Diethylstilbestrol (DES) exposure
- HIV seropositive
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 |
|---|---|---|
| di indolylmethane (DIM)This is the agent being studies. Similar agents have been reported to have potential activity. | Drug | oral DIM (Active agent) |
| Red rice branthis will act as the active comparator. The sponsor provided this as the "placebo" arm since it is a filler component of their DIM capsules | Dietary supplement | Red rice bran (Placebo) |
Primary outcome
Measure the regression of CIN in women by cytology, colposcopy, and biopsy,
Time frame: 3 months
To determine if oral DIM is effective in promoting the regression of CIN in women
2 secondary outcomes
HPV colonization by commercial ELIZA test
Time frame: 3 months
Adverse events reported by subjects and lab abnormalities i.e. CBC and SMA20
Time frame: one year
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 29 Mar 2017.
- Results publication: PubMed 19939441Del Priore G, Gudipudi DK, Montemarano N, Restivo AM, Malanowska-Stega J, Arslan AA. Oral diindolylmethane (DIM): pilot evaluation of a nonsurgical treatment for cervical dysplasia. Gynecol Oncol. 2010 Mar;116(3):464-7. doi: 10.1016/j.ygyno.2009.10.060. Epub 2009 Nov 24.
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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.
Giuseppe Del Priore, M.D., M.P.H. study director
NY Downtown Hospital
Alan Arslan, M.D. principal investigator
NYU School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing di indolylmethane (DIM) and Red rice bran in people with Cervical Dysplasia, run by New York Presbyterian Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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?
Measure the regression of CIN in women by cytology, colposcopy, and biopsy, (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00212381, which also lists 1 linked publication.
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 29 Mar 2017.