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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorŞule Güzle

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Routine Protective Oral Care

    Other intervention

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

  • Protective Oral Care Using Peppermint Oil Mouthwash

    Other intervention

    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.

Treatment groups

72 Participants
are divided into 2 treatment groups
Group A: Protective Oral Care Using Peppermint Oil Mouthwash GroupExperimental treatment 1 intervention
Group B: Routine Protective Oral Care GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
7 months
2

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.

Time frame
7 months
3

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.

Time frame
7 months

Secondary outcomes

1

Food Intake Status

Participants' food intake at meals will be recorded using the Food Intake Record Form. This tool will be used to evaluate how anorexia symptoms develop and their impact on nutritional intake. The form covers breakfast, lunch, dinner, and snacks, with consumption at each meal rated in percentage categories (0%, 25%, 50%, 75%, 100%). Daily intake will be calculated by summing the percentages across meals. Records will start one day prior to chemotherapy and continue on the chemotherapy day and for five consecutive days thereafter.

Time frame
7 months
2

Adherence and Monitoring of Peppermint Oil-Based Protective Oral Care

A Patient Monitoring Form will be created separately for the intervention and control groups. The form will include: RINVR scores, oral care assessment score, food intake records, appetite chart scores, oral care adherence, and allergic reaction follow-up. The form also includes information on the dates and time range (7 days / 10:00 PM-11:00 PM) of peppermint oil mouthwash application and protective oral care, as well as the name and dose of the antiemetic medication. Patients will be asked to document the times at which they perform oral care and complete the scales. Participants in the intervention group will perform peppermint mouthwash three times daily (morning, noon, evening) as part of the Peppermint Oil Protective Oral Care Protocol. Compliance will be documented in the Patient Monitoring Form. Gargling will begin on the day of chemotherapy and continue for five days thereafter.

Time frame
7 months
3

Monitoring of Allergic Reactions

The Allergic Reaction Monitoring Form will be used to examine adverse reactions associated with peppermint oil oral care. Participants in the intervention group will be evaluated with this form prior to, during, and 30 minutes after gargling. Local allergic symptoms such as mucosal erythema, burning, itching, and sensitivity will be recorded. Monitoring will start on the chemotherapy day and continue for five consecutive days.

Time frame
7 months
4

Anthropometric Measurements

Biomarkers that may be affected by nausea, vomiting, and anorexia symptoms-and thus influence nutritional status and patient outcomes-will be monitored. Participants' height (m) and weight (kg) will be measured and used to calculate Body Mass Index (BMI, kg/m²). Height and weight are combined to report a single BMI value. Data will be collected one day prior to chemotherapy and on the fifth day of chemotherapy. • Unit of Measure: kg/m²

Time frame
7 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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Şule Güzle

Lead sponsor

Ankara University

Sponsor institution

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