Colonic PolypsPhase 3MINT-CNCT02588248
L-Menthol Injection as a Novel Technique During Colonoscopy
A Phase 3 study testing Peppermint Oil in people with Colonic Polyps and Colon Cancer, run by University Hospitals Cleveland Medical Center at 1 site in United States.
Trial summary
The primary objective of this double-blinded, prospective, randomized placebo-controlled study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of peppermint oil solution vs placebo application during colonoscopy. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Colonic Polyps, Colon Cancer
- What is being tested?
- Peppermint Oil
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 82 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2017to 30 May 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 50 years of age in Caucasians or 45 years of age in African-Americans.
- Patients undergoing primary screening colonoscopy (either average risk or increased-risk) or surveillance colonoscopy after prior screening/surveillance colonoscopy.
- Capable of understanding instructions, adhering to study schedules and requirements, and willing to provide informed consent.
Who cannot join
- History of colectomy, partial or complete
- Symptoms suggesting possible colorectal stenosis or cancer
- Inflammatory bowel disease
- Familial polyposis syndromes
- History of, or current diagnosis of colorectal cancer
- American Society of Anesthesia Physical Stats (ASA PS) score of IV or greater
Show all 11Show fewer
- Non-correctable coagulopathy
- Currently receiving anti-thrombotic therapy, with an INR > 1.5
- Poor prep, total BBPS score < 6, or any part of the colon < 2.
- Patients with known allergy to peppermint oil or peppermint containing products.
- Patients taking calcium channel blockers (Amlodipine, Nifedipine, Verapamil, Diltiazem, Dihydropyridine, Felodipine, etc).
Trial locations and contacts
1 site in 1 country.
United States1 site
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
About this study
Official title: L-Menthol Injection as a Novel Technique During Colonoscopy: The MINT-C Study
The primary objective of this double-blinded, prospective, randomized placebo-controlled study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of peppermint oil solution vs placebo application during colonoscopy. The investigators hypothesize that ADR will be increased with the use of the peppermint oil solution and thus further reduce the risk of colon cancer by means of colonoscopy.
Read the detailed description
Adult subjects who are undergoing colonoscopy for primary colorectal cancer screening or surveillance. The study will be carried out as a prospective, double-blinded, fully-masked randomized controlled trial. Prior to the trial entry, the participant's labs and medical record will be reviewed in the electronic records system. If the subject meets inclusion/exclusion criteria, he or she will be consented at bedside prior undergoing their scheduled procedure and receive standard care as otherwise. Experimental and placebo solution ingredients will be serially numbered and randomized in a 1:1 ratio using a variable block strategy and provided by the institutional investigational pharmacy. Research staff will draw up experimental or placebo solution in 4 syringes with a total of 20mL in each solution.
The solutions are identical in appearance and endoscopic delivery. To prevent olfactory detection of the peppermint oil solution an essential oil diffuser will be used in all endoscopy rooms using the same oil as in the experimental solution. Endoscopists will be instructed to deliver the contents of one syringe sprayed via the endoscope in the cecum and one in the sigmoid colon. The contents of the other two syringes are to be delivered at the discretion of the endoscopist. After the procedure, endoscopists and study participants will be surveyed to determine if blinding was effective and to assess patient comfort levels, respectively. The primary and secondary end points will be determined on an intention to treat basis.
- Conditions
- Colonic Polyps, Colon Cancer
- Being tested
- Peppermint Oil, Placebo
- Keywords
- Colon Cancer, Colonic Polyps, L-Menthol, C-Mint
- Medical subject headings
- Colonic Polyps, Colonic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint OilDrug
Also called L-Menthol
During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640 mg of L-Menthol).
PlaceboOther
During the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B, also has 0 mg of L-Menthol).
| Study group | Role | What they receive |
|---|---|---|
| Peppermint Oil | Experimental | Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol)
Ingredients:
1. 16mL of peppermint oil (provided by the NowFoods® company)
2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
3. 1L prepackage sterile water
4. 2.6mL of undyed simethicone Receives: Drug: Peppermint Oil |
| Placebo | Placebo comparator | Solution B) Placebo solution
Ingredients:
1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution
2. 1L prepackage sterile water
3. 2.6mL of undyed simethicone
Instructions to prepare:
4. Add tween and simethicone to sterile water. Then, shake vigorously.
5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adenoma Detection Rates
Evaluate for changes in adenoma detection rates with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.
Measured: 2 weeks
Secondary outcomes (5)
Polyp Detection Rates
Evaluate for changes in Polyp detection rates.
Measured: 1 week .
Procedure Time
Evaluate for changes in total procedure time, cecal intubation time, and withdrawal time with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.
Measured: immediate
Advanced Adenoma Detection Rates
Evaluate for changes in advanced adenoma detection rates with the use of intraluminal peppermint oil application vs placebo during coloscopy. Advanced adenoma will be define as an adenoma with significant villous features (>25%), size of 1.0 cm or more, high-grade dysplasia, or early invasive cancer.
Measured: 2 weeks
Cancer Detection Rates
Evaluate for changes in cancer detection rates with the use of intraluminal peppermint oil application vs placebo during colonoscopy.
Measured: 2 weeks
Patient Comfort Level Recorded on Post-procedure Survey
Evaluate for changes in reported patient comfort levels with the use of intraluminal peppermint oil application vs placebo during colonoscopy.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2015 (estimated)
- Study start27 Apr 2017
- Primary completion30 May 2017
- Study completion30 May 2017
Why it stopped: Sponsor/Investigator has decided to close out the study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Colonic PolypsStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospitals Cleveland Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Richard C. K. Wong, MD., University Hospitals Cleveland Medical Center
- Investigators
- Richard Wong, MD, Principal investigator, University Hospitals Cleveland Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02588248
- Sponsor's protocol ID
- 05-15-07
- Acronym
- MINT-C
- Status last verified
- Mar 2022
- First submitted
- 6 Oct 2015
- Last updated
- 19 Apr 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- L-Menthol Injection as a Novel Technique During Colonoscopy: The MINT-C Study
- ClinicalTrials.gov ID
- NCT02588248
- Acronym / sponsor ID
- MINT-C / 05-15-07
- Conditions
- Colonic Polyps, Colon Cancer
- Keywords
- Colon Cancer, Colonic Polyps, L-Menthol, C-Mint
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor/Investigator has decided to close out the study
- Enrolment
- 82 participants (actual)
- Lead sponsor
- University Hospitals Cleveland Medical CenterUniversity, hospital or other
- Study start
- 27 Apr 2017 (actual)
- Primary completion
- 30 May 2017 (actual)
- Study completion
- 30 May 2017 (actual)
- First posted
- 27 Oct 2015 (estimated)
- Results
- Posted 19 Apr 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective of this double-blinded, prospective, randomized placebo-controlled study is to evaluate for change in endoscopic adenoma detection rates (ADR) with the use of peppermint oil solution vs placebo application during colonoscopy. The investigators hypothesize that ADR will be increased with the use of the peppermint oil solution and thus further reduce the risk of colon cancer by means of colonoscopy.
Detailed description
Adult subjects who are undergoing colonoscopy for primary colorectal cancer screening or surveillance. The study will be carried out as a prospective, double-blinded, fully-masked randomized controlled trial. Prior to the trial entry, the participant's labs and medical record will be reviewed in the electronic records system. If the subject meets inclusion/exclusion criteria, he or she will be consented at bedside prior undergoing their scheduled procedure and receive standard care as otherwise. Experimental and placebo solution ingredients will be serially numbered and randomized in a 1:1 ratio using a variable block strategy and provided by the institutional investigational pharmacy. Research staff will draw up experimental or placebo solution in 4 syringes with a total of 20mL in each solution.
The solutions are identical in appearance and endoscopic delivery. To prevent olfactory detection of the peppermint oil solution an essential oil diffuser will be used in all endoscopy rooms using the same oil as in the experimental solution. Endoscopists will be instructed to deliver the contents of one syringe sprayed via the endoscope in the cecum and one in the sigmoid colon. The contents of the other two syringes are to be delivered at the discretion of the endoscopist. After the procedure, endoscopists and study participants will be surveyed to determine if blinding was effective and to assess patient comfort levels, respectively. The primary and secondary end points will be determined on an intention to treat basis.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peppermint Oil | Experimental | Drug: Peppermint OilSolution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients: 1. 16mL of peppermint oil (provided by the NowFoods® company) 2. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 3. 1L prepackage sterile water 4. 2.6mL of undyed simethicone |
| Placebo | Placebo comparator | Other: PlaceboSolution B) Placebo solution Ingredients: 1. 0.4mL of Tween® 80 (i.e. Polysorbate 80) - this is a commonly used food additive that acts as a surfactant to bring the peppermint oil into solution 2. 1L prepackage sterile water 3. 2.6mL of undyed simethicone Instructions to prepare: 4. Add tween and simethicone to sterile water. Then, shake vigorously. 5. Once solution has settled, and patient has been randomized, draw 20mL of solution into a plastic syringe |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 50 years of age in Caucasians or 45 years of age in African-Americans.
- Patients undergoing primary screening colonoscopy (either average risk or increased-risk) or surveillance colonoscopy after prior screening/surveillance colonoscopy.
- Capable of understanding instructions, adhering to study schedules and requirements, and willing to provide informed consent.
Key exclusion criteria (11 listed)
- History of colectomy, partial or complete
- Symptoms suggesting possible colorectal stenosis or cancer
- Inflammatory bowel disease
- Familial polyposis syndromes
- History of, or current diagnosis of colorectal cancer
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 |
|---|---|---|
| Peppermint OilAlso: L-MentholDuring the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 640 mg of L-Menthol). | Drug | Peppermint Oil |
| PlaceboDuring the colonoscopy the Endoscopists will be required to deliver intraluminally 1 syringe at the cecum and 1 syringe in the sigmoid colon. Up to 2 additional doses can be delivered at the discretion of the endoscopist up to a maximum of 4 total doses (max total dose = 80 ml of Solution B, also has 0 mg of L-Menthol). | Other | Placebo |
Primary outcome
Adenoma Detection Rates
Time frame: 2 weeks
Evaluate for changes in adenoma detection rates with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.
5 secondary outcomes
Polyp Detection Rates
Time frame: 1 week .
Procedure Time
Time frame: immediate
Advanced Adenoma Detection Rates
Time frame: 2 weeks
Cancer Detection Rates
Time frame: 2 weeks
Patient Comfort Level Recorded on Post-procedure Survey
Time frame: 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Richard Wong, MD principal investigator
University Hospitals Cleveland Medical Center
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 Peppermint Oil in people with Colonic Polyps and Colon Cancer, run by University Hospitals Cleveland Medical Center 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 3 inclusion and 11 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: stopped early, as of the sponsor's last update on 19 Apr 2022. 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 19 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Adenoma Detection Rates (time frame: 2 weeks). 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 19 Apr 2022.