L-Menthol Injection as a Novel Technique During Colonoscopy

NCT ID: NCT02588248

Last Updated: 2022-04-19

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-27
• Study Completion Date: 2017-05-30

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.

Conditions

Colonic Polyps; Colon Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Peppermint Oil

Intervention Type: 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).

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: 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).

Interventions

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 = 640 mg of L-Menthol).

Intervention Type: DRUG

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, also has 0 mg of L-Menthol).

Intervention Type: OTHER

Other Intervention Names

L-Menthol

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).

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospitals Cleveland Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Richard C. K. Wong, MD.

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Richard Wong, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospitals Cleveland Medical Center

Locations

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

05-15-07

Identifier Type: -

Identifier Source: org_study_id