Clinical trial NCT02588248: L-Menthol Injection as a Novel Technique During Colonoscopy
Official title: L-Menthol Injection as a Novel Technique During Colonoscopy: The MINT-C Study
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Colonic Polyps
Colon Cancer
Keywords: Colon Cancer
Colonic Polyps
L-Menthol
C-Mint
Lead sponsor: University Hospitals Cleveland Medical Center
Sponsor class: OTHER
First posted: 2015-10-27
Enrollment: 82
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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.

Eligibility 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).

Primary outcomes:
measure: Adenoma Detection Rates
timeFrame: 2 weeks
Secondary outcomes:
measure: Polyp Detection Rates
timeFrame: 1 week .
measure: Procedure Time
timeFrame: immediate
measure: Advanced Adenoma Detection Rates
timeFrame: 2 weeks
measure: Cancer Detection Rates
timeFrame: 2 weeks
measure: Patient Comfort Level Recorded on Post-procedure Survey
timeFrame: 1 day
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center
name: Richard Wong, MD
role: PRINCIPAL_INVESTIGATOR
References: