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

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ClinicalTrials.gov Identifier: NCT04118322
Recruitment Status : Completed
First Posted : October 8, 2019
Last Update Posted : October 10, 2019
Sponsor:
Information provided by (Responsible Party):
Nuriye EFE ERTÜRK, TC Erciyes University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Chemotherapy Effect Adverse Effect Nursing Caries Other: aromatherapy (peppermint oil) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trials
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: The Effect of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
Actual Study Start Date : September 10, 2017
Actual Primary Completion Date : September 10, 2018
Actual Study Completion Date : September 10, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: intervention group
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.
Other: aromatherapy (peppermint oil)

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)


No Intervention: control group
The control group underwent only the routine treatment.



Primary Outcome Measures :
  1. Patient Information Form [ Time Frame: 1 day (first day) ]
    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.

  2. Visual Analog Scale (VAS)- Nausea Severity [ Time Frame: 1 day (fist day) ]
    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


Secondary Outcome Measures :
  1. Patient Watch Chart [ Time Frame: 1-5 days ]
    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.

  2. The Index of Nausea, Vomiting, and Retching- INVR [ Time Frame: 1-5 days ]
    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.

  3. Peppermint Oil Application Protocol [ Time Frame: 1-5 days ]
    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.

  4. Patient Opinions Form of Peppermint Oil Application [ Time Frame: only 1st and 5th day ]
    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.

  5. VAS-Patient Nausea Severity Follow-up Form [ Time Frame: 1-5 days ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Patients who

  • were aged ≥18 years,
  • were able to understand Turkish language and to communicate in Turkish language,
  • had cancer diagnosis,
  • received chemotherapy treatment for -at least- the second time with similar chemotherapeutic agents,
  • experienced nausea symptoms according to VAS
  • were not pregnant and not intending pregnancy,
  • had -at most- stage III cancer
  • presented no psychiatric disorders,
  • were not included in pre-implementation phase of the study were accepted to the study.

Exclusion Criteria:Patients who

  • suffered from another disease that may affect nausea vomiting status,
  • were allergic to or disturbed by smell of peppermint,
  • were newly diagnosed, and receiving chemotherapy for the first time,
  • received concomitant radiotherapy,
  • received other complementary and integrative health practices during the treatment were not accepted to the study

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118322


Locations
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Turkey
Nuriye EFE ERTURK
Batman, Central, Turkey
Sponsors and Collaborators
TC Erciyes University
Publications:
Lua PL, Salihah, Mazlan N. Effects of inhaled ginger aromatherapy on chemotherapy-induced nausea and vomiting and health-related quality of life in women with breast cancer. Complementary Therapies in Medicine 23: 396-404, 2015 https://doi.org/10.1016/j.ctim.2015.03.009. Zorba,P,Özdemir L. The preliminary effects of massage and inhalation aromatherapy on chemotherapy-induced acute nausea and vomiting. Cancer Nursing 41(5): 359-366, 2018 https://doi.org/10.1097/NCC.0000000000000496. Seale MK. The Use of Peppermint Oil to Reduce the Nausea of the Palliative Care and Hospice Patient [dissertation]. Boiling Springs, NC: School of Nursing, Gardner-Webb University.2012 Arslan M, Özdemir L. Oral intake of ginger for chemotherapy-induced nausea and vomiting among women with breast cancer. Clinical Journal of Oncology Nursing 19(5): E92-97, 2015 http://doi.org/10.1188/15.CJON.E92-E97. Muz G Taşcı S. Effect of aromatherapy via inhalation on the sleep quality and fatigue level in people undergoing hemodialysis. Applied Nursing Research, 37, 28-35, 2017 http://dx.doi.org/10.1016/j.apnr.2017.07.004. Rhodes V, Mc Daniel R. The index of nausea, vomiting and retching: A new format of the index of nausea and vomiting. Oncology Nursing Forum 26(5): 889-894, 1999.

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Responsible Party: Nuriye EFE ERTÜRK, PhD. Research Assistant, TC Erciyes University
ClinicalTrials.gov Identifier: NCT04118322    
Other Study ID Numbers: 2017/72
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 10, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Nuriye EFE ERTÜRK, TC Erciyes University:
Aromatherapy
Chemotherapy
Nausea-Vomiting
Nursing
Peppermint Oil
Additional relevant MeSH terms:
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Nausea
Vomiting
Signs and Symptoms, Digestive
Peppermint oil
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Parasympatholytics