The Effect of a Protective Oral Care Protocol Using Peppermint Oil Mouthwash

NCT07179094 | Not Yet Recruiting

• 1 other identifier: 125S390
• Study Type: interventional
• Target: 72
• Locations: 0 countries
• Sites: N/A

Brief Summary

Hematologic malignancies are the fifth most common type of cancer in the world. Patients with hematologic malignancies receive long-term and exhausting treatments such as chemotherapy, radiotherapy, hematopoietic stem cell transplantation and supportive therapies. Chemotherapy-induced nausea and vomiting has a significant impact on the daily lives of patients and causes physiological effects such as anorexia, malnutrition, weight loss, dehydration and electrolyte imbalance. It also has a negative impact on activities of daily living and psychological status, and may lead to poor adherence to chemotherapy regimens, refusal of chemotherapy or discontinuation of treatment. Oral mucosa is one of the areas most affected by the cytotoxic damage of chemotherapy. Disruption of the oral mucosa causes nausea, vomiting and feeding problems. Patients resort to non-drug approaches to manage these problems. It is important that these non-pharmacologic approaches are supported and controlled by reliable and evidence-based studies in order to prevent adverse effects on patient outcomes. In the literature, it has been determined that peppermint oil has antiemetic, antiseptic, anti-inflammatory, analgesic, antiseptic, antioxidant, antiviral, antifungal and spasmolytic effects, protects the integrity of the oral mucosa and has positive effects on nausea-vomiting and anorexia. In this context, the aim of the study was to investigate the effect of a preventive oral care protocol with peppermint oil mouthwash on chemotherapy-induced nausea, vomiting and appetite in patients with hematologic malignancy. Research Hypotheses H01: The protective oral care protocol applied with peppermint oil in patients with hematological malignancies has no effect on the development of chemotherapy-induced nausea and vomiting. H02: The protective oral care protocol applied with peppermint oil in patients with hematological malignancies has no effect on the severity of chemotherapy-induced nausea and vomiting. H03: The protective oral care protocol applied with peppermint oil in patients with hematological malignancies has no effect on the development of chemotherapy-induced anorexia. H04: The protective oral care protocol applied with peppermint oil in patients with hematological malignancies has no effect on the severity of chemotherapy-induced anorexia. Methods: The type of study is a single-blind randomized controlled experimental study. The research will be conducted between September 10, 2025, and April 10, 2026, with patients admitted to the hematology clinic of a university hospital for chemotherapy treatment. The study will be conducted with a total of 72 people who will be randomly assigned to the intervention (n=36) and control groups (n=36) by stratified and block randomization method. Patients who are 18 years of age or older, have hematologic malignancy, with a history of at least one chemotherapy cycle, and scheduled to receive chemotherapy with high or moderate emetogenic risk agents, do not have oral mucositis before chemotherapy, do not have metastasis, are literate and volunteer to participate in the study will be included in the study. Research data will be collected using the "Patient Introduction Form", "Rhodes Nausea-Vomiting and Retching Index", "Oral Assessment Guide", "Appetite Assessment Chart \[(Visual Analog Scale (VAS)\]", "Peppermint Oil Protective Oral Care Protocol", "Food Intake Record Form", "Allergic Reaction Monitoring Form" and "Patient Monitoring Form and Antiemetic Record Chart". In addition to the routine protective oral care (saline solution mouthwash and/or sodium bicarbonate mouthwash) in the clinic, "Peppermint Oil Protective Oral Care Protocol" will be applied to the intervention group for 6 days from the start of chemotherapy treatment. Patients will receive mouthwash prepared with 1 ml of peppermint oil and 50 ml of prepared drinking water 3 times a day. Patients in the intervention group will be monitored for 6 days by evaluating oral assessment, development of oral mucositis, appetite follow-up and compliance with mouthwash. The development of allergy due to the use of peppermint oil in each mouthwash application will be evaluated. The control group will not receive any oral care intervention by the researcher and will receive routine preventive oral care in the clinic. In the evaluation of the data, descriptive statistics, Chi-square / Fisher's Exact test will be used for the relationship between categorical variables, Mann Whitney U test, Wilcoxon test, Kruskal-Wallis H test will be used for the relationship between continuous variables in groups that do not show normal distribution; one-way analysis of variance / repeated measures analysis of variance, t test for dependent and independent groups will be used in groups with normal distribution. Correlation analysis and regression analysis will be used to examine the relationship between variables.

Conditions

Hematologic Neoplasms; Nausea; Vomiting; Anorexia

Keywords

Hematologic Neoplasms; Nausea; Vomiting; Anorexia; Prevention Mouthrinse; peppermint oil

Outcome Measures

Primary Outcomes (3)

• Nausea-Vomiting-Retching Symptoms

  The nausea, vomiting, and retching symptoms that may develop due to chemotherapy will be assessed using the Rhodes Index of Nausea, Vomiting, and Retching (RINVR). The scale consists of eight items measuring the frequency, duration, and severity of symptoms. In scoring, each response ranges from 0 (no distress) to 4 (maximum distress). The patient's experiences across all eight items are summed, with a maximum possible score of 32, indicating the most severe symptom burden. The index comprises three sub-dimensions: symptom experience, symptom occurrence, and symptom distress. Assessments will begin one day prior to chemotherapy and will continue on the day of chemotherapy and for five consecutive days thereafter.

  7 months

• Oral Health Status

  The oral mucosal conditions of participants will be evaluated using the Oral Assessment Guide (OAG). This guide assesses dentures, teeth, gums, mucous membranes, saliva, tongue, lips, swallowing, and voice. Each item is scored from 1 to 3, and total scores are obtained by summation, ranging between 8 and 24. Lower scores indicate better oral health, while higher scores reflect deterioration. According to the OAG: * 8-14 points: At risk for oral health deterioration * 15-24 points: Presence of oral health deterioration Evaluations will begin one day prior to chemotherapy and will be conducted on the chemotherapy day and for five consecutive days thereafter.

  7 months

• Anorexia Symptom

  Participants' anorexia symptoms will be assessed using the Appetite Assessment Chart \[Visual Analog Scale (VAS)\]. The chart consists of a 100 millimeters horizontal line, and scores are determined by measuring the distance (in mm) between the left anchor and the point marked by the patient. * Left anchor (0): "My appetite is very good" * Right anchor (10): "I have no appetite at all" Scores range from 0 to 10, with higher scores indicating greater severity of anorexia symptoms. Participants will be asked to make one marking per 24-hour period to reflect their appetite status. Assessments will start one day prior to chemotherapy and will continue on the day of chemotherapy and for five consecutive days thereafter.

  7 months

Secondary Outcomes (9)

• Food Intake Status

  7 months

• Adherence and Monitoring of Peppermint Oil-Based Protective Oral Care

  7 months

• Monitoring of Allergic Reactions

  7 months

• Anthropometric Measurements

  7 months

• Biochemical Findings - mg/dL

  7 months

Study Arms (2)

Protective Oral Care Using Peppermint Oil Mouthwash Group

EXPERIMENTAL

The Protective Oral Care Application with Peppermint Oil will begin on the first day of chemotherapy (Day 0) and will continue for the following five days. Patients in this group will be instructed to perform oral care with peppermint oil mouthwash three times daily for six consecutive days (Day 0, Day 1, Day 2, Day 3, Day 4, Day 5). In addition, patients will be asked to evaluate their throat and oral mucosa immediately before the application, during the application, and 30 minutes after the application using the Allergic Reaction Monitoring Form. Peppermint oil mouthwash will be administered at the following times: * 07:00-08:00 (morning) * 15:00-16:00 (afternoon) * 22:00-23:00 (night) At each application, patients will complete the Allergic Reaction Monitoring Form to record local allergic symptoms such as erythema, burning, itching, and sensitivity.

Other: Protective Oral Care Using Peppermint Oil Mouthwash

Routine Protective Oral Care Group

ACTIVE COMPARATOR

Participants in this group will perform oral care according to the routine clinical oral care procedures applied in the oncology clinic. This includes the use of saline solution mouthwash and/or sodium bicarbonate mouthwash. The routine oral care will be carried out on the day of chemotherapy and for the following five days (a total of six consecutive days).

Other: Routine Protective Oral Care

Interventions

Routine Protective Oral Care OTHER

In the control group, this group will perform oral care according to the routine clinical oral care procedures applied in the oncology clinic.

Routine Protective Oral Care Group

Protective Oral Care Using Peppermint Oil Mouthwash OTHER

Patients in the intervention group will perform a mouth rinse three times daily using 1 mL of peppermint oil diluted in 50 mL of water. The first application will be initiated on the day of chemotherapy, and patients will continue the peppermint oil oral care for six consecutive days (Day 0, Day 1, Day 2, Day 3, Day 4, and Day 5). The peppermint oil oral care protocol is scheduled to be administered at 07:00-08:00, 15:00-16:00, and 22:00-23:00, taking into account the routine timing of antiemetic medication administration in the clinic. The detailed description of the oral care protocol is presented below.

Protective Oral Care Using Peppermint Oil Mouthwash Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older
• Clinical diagnosis of hematologic malignancy
• History of at least one chemotherapy cycle
• Scheduled to receive chemotherapy with high or moderate emetogenic risk agents
• No oral mucositis before chemotherapy
• No metastasis
• Literate (able to read and write)
• Volunteer to participate in the study

You may not qualify if:

• Use of herbal remedies for nausea, vomiting, or anorexia
• Concurrent radiotherapy with chemotherapy
• Non-adherence to standard antiemetic therapy according to the chemotherapy preparation regimen and protocol (e.g., use of antiemetics other than granisetron or metoclopramide)
• Known allergy to peppermint oil
• Psychiatric disorders
• Communication impairments (hearing or speech difficulties)
• Altered level of consciousness
• Endotracheal intubation
• Requirement for oral care solutions other than the clinic's routine procedures (saline or sodium bicarbonate)
• Chronic gastrointestinal diseases (gastritis, gastric/peptic ulcer, ulcerative colitis, Crohn's disease, gastroesophageal reflux, irritable bowel syndrome, cirrhosis, or pancreatitis)
• Migraine
• Brain metastases
• Hepatic or renal insufficiency
• Administration of low-emetogenic chemotherapy
• Mucositis (Oral Assessment Guide score: 15-24 points)

Sponsors & Collaborators

• Şule Güzle: lead

Related Publications (6)

• Tipton JM, McDaniel RW, Barbour L, Johnston MP, Kayne M, LeRoy P, Ripple ML. Putting evidence into practice: evidence-based interventions to prevent, manage, and treat chemotherapy-induced nausea and vomiting. Clin J Oncol Nurs. 2007 Feb;11(1):69-78. doi: 10.1188/07.CJON.69-78.

  PMID: 17441398 BACKGROUND

• Khaddour K, Hana CK, Mewawalla P. Hematopoietic Stem Cell Transplantation. 2023 May 6. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2025 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK536951/

  PMID: 30725636 BACKGROUND

• Kennedy SKF, Goodall S, Lee SF, DeAngelis C, Jocko A, Charbonneau F, Wang K, Pasetka M, Ko YJ, Wong HCY, Chan AW, Rajeswaran T, Gojsevic M, Chow E, Gralla RJ, Ng TL, Jerzak KJ. 2020 ASCO, 2023 NCCN, 2023 MASCC/ESMO, and 2019 CCO: a comparison of antiemetic guidelines for the treatment of chemotherapy-induced nausea and vomiting in cancer patients. Support Care Cancer. 2024 Apr 10;32(5):280. doi: 10.1007/s00520-024-08462-x.

  PMID: 38594320 BACKGROUND

• Evans A, Malvar J, Garretson C, Pedroja Kolovos E, Baron Nelson M. The Use of Aromatherapy to Reduce Chemotherapy-Induced Nausea in Children With Cancer: A Randomized, Double-Blind, Placebo-Controlled Trial. J Pediatr Oncol Nurs. 2018 Nov/Dec;35(6):392-398. doi: 10.1177/1043454218782133. Epub 2018 Jun 27.

  PMID: 29947285 BACKGROUND

• Tavakoli Ardakani M, Ghassemi S, Mehdizadeh M, Mojab F, Salamzadeh J, Ghassemi S, Hajifathali A. Evaluating the effect of Matricaria recutita and Mentha piperita herbal mouthwash on management of oral mucositis in patients undergoing hematopoietic stem cell transplantation: A randomized, double blind, placebo controlled clinical trial. Complement Ther Med. 2016 Dec;29:29-34. doi: 10.1016/j.ctim.2016.08.001. Epub 2016 Aug 30.

  PMID: 27912953 BACKGROUND

• Jafarimanesh H, Akbari M, Hoseinian R, Zarei M, Harorani M. The Effect of Peppermint (Mentha piperita) Extract on the Severity of Nausea, Vomiting and Anorexia in Patients with Breast Cancer Undergoing Chemotherapy: A Randomized Controlled Trial. Integr Cancer Ther. 2020 Jan-Dec;19:1534735420967084. doi: 10.1177/1534735420967084.

  PMID: 33118401 BACKGROUND

Related Links

• Randomization

MeSH Terms

Conditions

Hematologic Neoplasms; Nausea; Vomiting; Anorexia

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

şule g Güzle

CONTACT

+90 545 804 27 43; sulegzle222@gmail.com

Ayşegül ö Öztürk Birge

CONTACT

+90 505 923 92 01; birge@ankara.edu.tr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 9, 2025
• First Posted: September 17, 2025
• Study Start: September 10, 2025
• Primary Completion: April 10, 2026
• Study Completion (Estimated): June 10, 2026
• Last Updated: September 17, 2025

Record last verified: 2025-09