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Sponsor/Investigator has decided to close out the study
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Peppermint Oil | Experimental | Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients:
|
|
| Placebo | Placebo Comparator | Solution B) Placebo solution Ingredients:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Peppermint Oil | Drug | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Adenoma Detection Rates | Evaluate for changes in adenoma detection rates with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy. | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Polyp Detection Rates | Evaluate for changes in Polyp detection rates. | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Wong, MD | University Hospitals Cleveland Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | 44106 | United States |
Patients will be questioned regarding their allergy status specific to peppermint oil and this will be documented in the consent form and in the RedCap database. The patient must meet all inclusion and exclusion criteria and willing to participate in informed consent.
Day1 - patients undergoing screening and surveillance colonoscopy are pre-screened to evaluate if they meet inclusion criteria.
Once identified patient is approached by study personnel to determine their willingness. If willing to participate will undergo written consent for participation. Patients will be followed up by telephone for adverse reactions at 24-48 hr, one week and one month after colonoscopy.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Solution B) Placebo solution Ingredients:
Placebo: 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 Solution B which contains 0 mg of L-Menthol). |
| FG001 | Peppermint Oil | Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients:
Peppermint Oil: 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 = 640mg L-Menthol). |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
The study protocol did not collect race or ethnicity.
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Solution B) Placebo solution Ingredients:
Placebo: 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 ; with 0 mg of L-Methol). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Adenoma Detection Rates | Evaluate for changes in adenoma detection rates with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy. | Posted | Count of Participants | Participants | 2 weeks |
|
Patients were assessed day one after procedure, 24-48 after, one week and one month after procedure
patients were assessed and graded by AE definitions adapted from the National Cancer Institute Common Terminology Criteria for Adverse Events. Grades 1 through 5. Data was stored in RedCap.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Peppermint Oil | Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients:
Peppermint Oil: 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 = 640mg Placebo). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| bloating and cramping | Gastrointestinal disorders | Grade 1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| L-Menthol Injection as a Novel Technique during Colonoscopy: The MINT-C study | UHClevelandMC | 216-844-1000 | 6172 | Richard.wong@UHhospitals.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 21, 2018 | Mar 23, 2022 | Prot_SAP_002.pdf |
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| ID | Term |
|---|---|
| D003111 | Colonic Polyps |
| D003110 | Colonic Neoplasms |
| ID | Term |
|---|---|
| D007417 | Intestinal Polyps |
| D011127 | Polyps |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C015424 | peppermint oil |
| D008610 | Menthol |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 |
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|
|
| Placebo | Other | 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). |
|
| 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. | 2 weeks |
| Cancer Detection Rates | Evaluate for changes in cancer detection rates with the use of intraluminal peppermint oil application vs placebo during colonoscopy. | 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. | 1 day |
| BG001 | Peppermint Oil | Solution A) Peppermint oil solution (1.6% peppermint oil, which is 0.8% L-menthol) Ingredients:
Peppermint Oil: 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 = 640mg L-Menthol). |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG001 | Placebo | Solution B) Placebo solution Ingredients:
Placebo: 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 ; 0 mg of L-Menthol) |
|
|
| Secondary | Polyp Detection Rates | Evaluate for changes in Polyp detection rates. | Posted | Count of Participants | Participants | 1 week . |
|
|
|
| Secondary | 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. | Note that total procedure time was not collected | Posted | Median | Full Range | minutes | immediate |
|
|
|
| Secondary | 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. | The data was not entered in the database in a format that would allow it to be collated according to the definition above. Also, some subjects did show more than one advanced adenoma. | Posted | Number | participants | 2 weeks |
|
|
|
| Secondary | Cancer Detection Rates | Evaluate for changes in cancer detection rates with the use of intraluminal peppermint oil application vs placebo during colonoscopy. | Posted | Count of Participants | Participants | 2 weeks |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | 1 day |
|
|
|
| 0 |
| 37 |
| 0 |
| 37 |
| 7 |
| 37 |
| EG001 | Placebo | Solution B) Placebo solution Ingredients:
Placebo: 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 = 640mg Placebo). | 0 | 38 | 0 | 38 | 8 | 38 |
| Loss of appetite | Gastrointestinal disorders | Grade 1 | Systematic Assessment |
|
| cramping | Gastrointestinal disorders | Grade 1 | Systematic Assessment |
|
| bloating | Gastrointestinal disorders | Grade 1 | Systematic Assessment |
|
| bumps | Skin and subcutaneous tissue disorders | Grade 1 | Systematic Assessment |
|
| constipation and bloating | Gastrointestinal disorders | Grade 1 | Systematic Assessment |
|
| constipation | Gastrointestinal disorders | Grade 1 | Systematic Assessment |
|
| heartburn | Gastrointestinal disorders | Grade 1 | Systematic Assessment |
|
| hemorrhoids | Gastrointestinal disorders | Grade 1 | Systematic Assessment |
|
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| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| Organic Chemicals |
| D000081005 | Cyclohexane Monoterpenes |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D039821 | Monoterpenes |
| D013729 | Terpenes |
| D008055 | Lipids |
| Villous Adenoma |
|
| Serrated Adenoma |
|
| Cancer |
|
| No Adenoma |
|
| Moderate(bothersome) |
|
| Severe |
|
| Not available |
|