L-Menthol Injection as a Novel Technique During Colonoscopy

NCT02588248 | Terminated Phase 3 Results DMC FDA Drug

• 1 other identifier: 05-15-07
• Study Type: interventional
• Target: 82
• Locations: 1 country
• Sites: 1

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.

Conditions

Colonic Polyps; Colon Cancer

Keywords

Colon Cancer; Colonic Polyps; L-Menthol; C-Mint

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (5)

• Polyp Detection Rates

  1 week .

• Procedure Time

  immediate

• Advanced Adenoma Detection Rates

  2 weeks

• Cancer Detection Rates

  2 weeks

• Patient Comfort Level Recorded on Post-procedure Survey

  1 day

Study Arms (2)

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

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

Other: Placebo

Interventions

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).

Also known as: L-Menthol

Peppermint Oil

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).

Placebo

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• 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).

Sponsors & Collaborators

• University Hospitals Cleveland Medical Center: lead

Study Sites (1)

University Hospitals Cleveland Medical Center

Cleveland, Ohio, 44106, United States

Location

MeSH Terms

Conditions

Colonic Polyps; Colonic Neoplasms

Interventions

peppermint oil; Menthol

Condition Hierarchy (Ancestors)

Intestinal Polyps; Polyps; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Cyclohexanols; Hexanols; Fatty Alcohols; Alcohols; Organic Chemicals; Cyclohexane Monoterpenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Monoterpenes; Terpenes; Lipids

Results Point of Contact

• Title: L-Menthol Injection as a Novel Technique during Colonoscopy: The MINT-C study
• Organization: UHClevelandMC

Richard.wong@UHhospitals.org

216-844-1000

Study Officials

• Richard Wong, MD

  University Hospitals Cleveland Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: October 6, 2015
• First Posted: October 27, 2015
• Study Start: April 27, 2017
• Primary Completion: May 30, 2017
• Study Completion: May 30, 2017
• Last Updated: April 19, 2022
• Results First Posted: April 19, 2022

Record last verified: 2022-03

Locations

US (1)