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Menthol

Peppermint oil

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Peppermint

Cola

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

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

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).

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 = 80 ml of Solution B, also has 0 mg of L-Menthol).

Placebo

Richard Wong, MD

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.

L-Menthol Injection as a Novel Technique During Colonoscopy

L-Menthol Injection as a Novel Technique During Colonoscopy: The MINT-C Study

Evaluate for changes in adenoma detection rates with the use of intraluminal peppermint oil application vs sterile water application during colonoscopy.

Evaluate for changes in Polyp detection rates.

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.

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.

Evaluate for changes in cancer detection rates with the use of intraluminal peppermint oil application vs placebo during colonoscopy.

Evaluate for changes in reported patient comfort levels with the use of intraluminal peppermint oil application vs placebo during colonoscopy.

University Hospitals Cleveland Medical Center

M.D.

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.

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

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).

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

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).

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

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).

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

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).

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race and Ethnicity were not collected from any participant.

Race and Ethnicity Not Collected

United States

Region of Enrollment

The study protocol did not collect race or ethnicity.

L-Menthol Injection as a Novel Technique during Colonoscopy: The MINT-C study

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

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)

Adenoma Detection Rates

Polyp Detection Rates

Cecal Intubation time in minutes

Withdraw Time in minutes

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

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-Mentol).

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

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).

Note that total procedure time was not collected

Procedure Time

Tubular Adenoma

Tubulovillous Adenoma

Villous Adenoma

Serrated Adenoma

Cancer

No Adenoma

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

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).

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.

Advanced Adenoma Detection Rates

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

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-Methol).

Cancer Detection Rates

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

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; 0mg of L- Menthol).

Patient Comfort Level Recorded on Post-procedure Survey

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

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).

Overall Study

Nausea

Vomiting

Signs and Symptoms, Digestive

The patients in the intervention group applied peppermint oil (3%) on lips three times a day, during the five days following chemotherapy administration, in addition to the standard antiemetic treatments. The data were collected using a Patient Information Form, Rhodes Index of Nausea, Vomiting and Retching (INVR), Visual Analog Scale (VAS) Patient Nausea Severity Follow-up Form, Patient Watch Chart, and Oil Application Protocol. Besides, patients in the intervention group were questioned thoughts associated with peppermint oil application using individual in-depth interview method.

The control group underwent only the routine treatment.

The patients in the intervention group received routine medical treatment program and were asked to put one drop of peppermint oil upon lips following chemotherapy administration. Before peppermint oil application; the researcher theoretically and practically provided a training of 8-10 minutes about the use of peppermint oil and the patients were requested to apply this oil three times a day according to "Oil Practice Guide" (See Fig. 2) in the morning (09:00), at noon (15:00) and in the evening (21:00).

Aromatherapy essential oil used was a mixture of English peppermint (Mentha piperita; 3%) and sweet almond oil (30 ml)

aromatherapy (peppermint oil)

The aim of this study was to determine the effect of peppermint oil upon incidence of nausea, vomiting and retching, nause severity, and the usage amount of antiemetics in cancer patients undergoing chemotherapy.

Nausea, vomiting and retching symptoms are among the most common adverse effects of chemotherapy and are defined with expressions like "the biggest problem including pain" by patients. Chemotherapy-induced nausea and vomiting (CINV)' is reported leads to fluid-electrolyte imbalance, dehydration, loss of weight, physiological effects caused by poor drug absorption or decreased elimination from kidneys as well as negative effects in one's social life, work-life, activities of daily life and psychological status. Also, nausea-vomiting may cause some patients to refuse chemotherapy or to discontinue the treatment. Inadequate control of CINV leads patients to integrative health practices.

The study was realized as a randomized controlled study in order to explore the effect of use of 3% peppermint oil applied on lips three times a day during the five days following chemotherapy upon incidence nausea, vomiting, and retching, nausea severity and quantity use of antiemetics in cancer patients undergoing chemotherapy.The study was initiated on the 10.09.2017 and in this study were interviewed with 250 patients. 90 patients that met inclusion criteria were contacted. The study was completed with 36 intervention patients and with 44 control patients (See Fig. 1). For determine to sample size, while patients were being allocated to the study groups, post hoc power analysis was periodically done with the data obtained. The sample size for this study was calculated using the MedCalc (32-bit). The process continued until the necessary sample size was reached. According to power analysis, α = 0.05 and β =0.20, and the power of the study was 99.9%.

Randomization In order to provide randomization was preferred ballot method. As a result of the ballot, the first patient who inclusion criteria of study was allocated to the intervention group while the next one to the control group. After participant enrollment, patients were assigned to the two groups in a 1:1 ratio according to this rule. Because of it is not known whether nausea/vomiting experience of patients who first time chemotherapy receiving, study groups included patients receiving two or more chemotherapy.

Interventions 2.4.1. The control group The control group underwent only the routine treatment. The patients in the control group, Patient Watch Chart, Patient Nausea Severity Follow-up Form, and INVR, marked by patients and They were returned the duly completed these forms to the researcher when they came to hospital for the next chemotherapy treatment. Patient Watch Chart, and INVR skala of patients who illiterate were filled in by the pollster, according to expression of patient. In order to fill in Patient Watch Chart, and INVR phone interviews were made twice a day (morning-evening) by the pollster and the participants at a suitable time determined together.

2.4.2. Intervention group The patients in the intervention group received routine medical treatment program and were asked to put one drop of peppermint oil upon lips following chemotherapy administration. Before peppermint oil application; the researcher theoretically and practically provided a training of 8-10 minutes about the use of peppermint oil and the patients were requested to apply this oil three times a day according to "Oil Practice Guide" (See Fig. 2) in the morning (09:00), at noon (15:00) and in the evening (21:00). The mobile phones of the participants were set to these hours and the alarm system continued in this manner for five days. The participants whose mobile phones were not set to these hours were called by the researcher in order to recall them of the protocol. Before peppermint oil application, Patient Opinion Form (pre-application) were asked to the participants and their answers were written down. Similarly; after peppermint oil application, same form (post-application) were asked and the answers were written down. Patient Watch Chart, Patient Nausea Severity Follow-up Form, and INVR, marked by patients and They were returned the duly completed these forms to the researcher when they came to hospital for the next chemotherapy treatment. Patient Watch Chart, and INVR skala of patients who illiterate were filled in by the pollster, according to expression of patient. In order to fill in Patient Watch Chart, and INVR phone interviews were made twice a day (morning-evening) by the pollster and the participants at a suitable time determined together.

Patients in the intervention and control groups were allowed to take standard antiemetic medications and other drugs taken for different medical problems during and after the day of peppermint oil application. As a part of standard antiemetic treatment; patients were given " in isotonic solution 5-HT3 receptor antagonists (palonosetron, granisetron (Kytril))+ steroids (dexamethazon (Decort)) + antihistaminic (Avil or Systral ampul) + Metpamid ampul" before chemotherapy.

Onzyd 8 mg (ondansetron) + metpamid tb. has been prescribed by oncologist, for able to use at patient's home.

The Effect of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy

The Effect of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial

The form was consisted of 17 statements in order to explore patients' socio-demographic characteristics (age, sex, educational status, marital status, number of children, etc.), and diagnosis, treatment protocol, and complementary and integrative health practices used to cope with cancer and nausea-vomiting symptoms.

The scale (VAS) was used to accept patients to the study. VAS is composed of 10-cm (100 mm) line which at the left end by words "No nausea 0" and increased numbers indicated rising nause levels; at the right end "Severe nausea 10". The patient is asked to place a mark on the scale to indicate the level of intensity of his or her nausea. Distance of patient's mark to left end is measured with a ruler in millimeter and is accepted and written as score

The form was separately designed for the intervention and control groups after a thorough review of the relevant literature. Patient Watch Chart was designed to explore status of use of antiemetics prescribed only by physicians for the patients in the control group while in the intervention group, to explore status of use of antiemetics and status of peppermint oil.

The index was developed by Rhodes V. and Mc Daniel R. (Rhodes \& Mc Daniel, 1999) in order to explore post chemotherapy nausea, vomiting, and retching frecuency and distresses that patients experience. The index is composed of 8 questions. Assign a numeric value to each response from 0, (the least amount of distress), to 4, (the most distress). Total symptom experience from nausea and vomiting is calculated by summing the patient's responses to each of the eight items on the Rhodes INV. The potential range of scores is from a low of 0 to a maximum of 32. Patients are required to fill in the form in the most suitable period of 12 hours that they decide. There are three subdimensions: symptoms experience, symptoms occurrence, and symptoms distress. In order to score the INVR; 1st, 3rd, 6th and 7th items should be reversed.

The guideline were prepared in line with expert opinion and literature in order to show stages and important oints of oil application and to make sure that the oil application would be carried out in the same manner by all the patients. The aromatherapy essential oil used was a mixture of English peppermint (Mentha piperita; 3%) and sweet almond oil (30 ml), Patients were informed of keeping the aromatic mixture in a closed and dark bottle, in a cool place and away from sunshine. The peppermint oil application was carried out according to Oil Practice Guide (See Fig. 2) by the patients in the intervention group.

The form included semi-structured questions designed in line with expert opinions and literature in order to identify opinions of the patients in the intervention group about the peppermint oil application (Muz \& Taşcı, 2017). The questions in the form were asked to the patients before and after peppermint oil application and patient opinions were voice-recorded or written down. Before peppermint oil application; the questions ("What do nausea and/or vomiting mean for you?, How do these symptoms influence your life?, Do you believe that the oil to be used will help lessen your symptoms?") were asked whereas after peppermint oil application; the questions ("Do you think that peppermint oil application has had effect upon nausea, vomiting, and retching symptoms?, How has peppermint oil application affected your daily life?, What are the easy and difficult sides of peppermint oil application?") were asked to explore patient views.

In order to assess severity of nausea experienced by patients after chemotherapy administration; VAS- Patient Nausea Severity Follow-up Form was developed by the researcher and marked by the patients in intervention group and control group. The form consists of VASs that marked two times a day -in the morning and in the evening- during five days (Zorba \& Özdemir, 2018; Arslan \& Özdemir, 2015). Marking and evaluation of the VAS's in the form were done according to the principles in the Visual Analogue Scale (VAS) - Severity of Nausea.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
L-Menthol Injection as a Novel Technique During Colonoscopy	NCT02588248	Colonic Polyps Colon Cancer	Peppermint Oil Placebo	45 Years -	University Hospitals Cleveland Medical Center
The Effect of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy	NCT04118322	Chemotherapy Ef... Adverse Effect Nursing Caries	aromatherapy (p...	18 Years -	TC Erciyes University
The Effect of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy	NCT04118322	Chemotherapy Ef... Adverse Effect Nursing Caries	aromatherapy (p...	18 Years -	TC Erciyes University

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