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L-Menthol Infusion as a Novel Technique During Colonoscopy (MINT-C)

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ClinicalTrials.gov Identifier: NCT02588248
Recruitment Status : Not yet recruiting
First Posted : October 27, 2015
Last Update Posted : October 5, 2018
Sponsor:
Information provided by (Responsible Party):
Richard C. K. Wong, MD., University Hospitals Cleveland Medical Center

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Colonic Polyps Colon Cancer Drug: Peppermint Oil Other: Placebo Phase 3

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Diagnostic
Official Title: L-Menthol Infusion as a Novel Technique During Colonoscopy: The MINT-C Study
Estimated Study Start Date : October 30, 2018
Estimated Primary Completion Date : October 30, 2021
Estimated Study Completion Date : April 30, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Peppermint Oil

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
Drug: 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).
Other Name: L-Menthol

Placebo Comparator: Placebo

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
Other: 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).




Primary Outcome Measures :
  1. Adenoma Detection Rates [ Time Frame: 2 weeks ]
    Collected and recorded after pathology results are made available


Secondary Outcome Measures :
  1. Procedure time [ Time Frame: immediate ]
    Change in procedure time with compare to placebo

  2. Advanced adenoma detection rates [ Time Frame: 2 weeks ]
    Collected and recorded after pathology results are made available

  3. Cancer detection rates [ Time Frame: 2 weeks ]
    Collected and recorded after pathology results are made available

  4. Patient comfort level recorded on post-procedure survey [ Time Frame: 1 day ]
    Pt reported comfort level recorded on post-procedure survey

  5. Polyp Detection Rates [ Time Frame: 2 weeks ]
    Collected and recorded after pathology results are made available



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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. At least 50 years of age in Caucasians or 45 years of age in African-Americans.
  2. Patients undergoing primary screening colonoscopy (either average risk or increased-risk) or surveillance colonoscopy after prior screening/surveillance colonoscopy.
  3. Capable of understanding instructions, adhering to study schedules and requirements, and willing to provide informed consent.

Exclusion Criteria:

  1. History of colectomy, partial or complete
  2. Symptoms suggesting possible colorectal stenosis or cancer
  3. Inflammatory bowel disease
  4. Familial polyposis syndromes
  5. History of, or current diagnosis of colorectal cancer
  6. American Society of Anesthesia Physical Stats (ASA PS) score of IV or greater
  7. Non-correctable coagulopathy
  8. Currently receiving anti-thrombotic therapy, with an INR > 1.5
  9. Poor prep, total BBPS score < 6, or any part of the colon < 2.
  10. Patients with known allergy to peppermint oil or peppermint containing products.
  11. Patients taking calcium channel blockers (Amlodipine, Nifedipine, Verapamil, Diltiazem, Dihydropyridine, Felodipine, etc).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02588248


Contacts
Contact: Neetika Srivastava, MD (216) 844-3217 Neetika.Srivastava@UHhospitals.org

Locations
United States, Ohio
University Hospitals Cleveland Medical Center Not yet recruiting
Cleveland, Ohio, United States, 44106
Contact: Richard Wong, MD    216-844-6172    Richard.Wong@UHhospitals.org   
Contact: Neetika Srivastava, MD    (216) 844-3217    Neetika.Srivastava@UHhospitals.org   
Principal Investigator: Richard Wong, MD         
Sub-Investigator: Neetika Srivastava, MD         
Sponsors and Collaborators
University Hospitals Cleveland Medical Center
Investigators
Principal Investigator: Richard Wong, MD University Hospitals Cleveland Medical Center

Responsible Party: Richard C. K. Wong, MD., M.D., University Hospitals Cleveland Medical Center
ClinicalTrials.gov Identifier: NCT02588248     History of Changes
Other Study ID Numbers: 05-15-07
First Posted: October 27, 2015    Key Record Dates
Last Update Posted: October 5, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Richard C. K. Wong, MD., University Hospitals Cleveland Medical Center:
Colon Cancer
Colonic Polyps
L-Menthol
C-Mint

Additional relevant MeSH terms:
Colonic Neoplasms
Colonic Polyps
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Intestinal Polyps
Polyps
Pathological Conditions, Anatomical
Menthol
Peppermint oil
Antipruritics
Dermatologic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics