Chemotherapy Effect Clinical Trial
Official title:
The Effect of Peppermint Oil on Nausea, Vomiting and Retching in Cancer Patients Undergoing Chemotherapy: A Randomized Controlled Trial
Verified date | October 2019 |
Source | TC Erciyes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | September 10, 2018 |
Est. primary completion date | September 10, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Turkey | Nuriye EFE ERTURK | Batman | Central |
Lead Sponsor | Collaborator |
---|---|
TC Erciyes University |
Turkey,
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 Tasci 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.
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Information Form | 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. | 1 day (first day) | |
Primary | Visual Analog Scale (VAS)- Nausea Severity | 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 | 1 day (fist day) | |
Secondary | Patient Watch Chart | 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. | 1-5 days | |
Secondary | The Index of Nausea, Vomiting, and Retching- INVR | 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. | 1-5 days | |
Secondary | Peppermint Oil Application Protocol | 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. | 1-5 days | |
Secondary | Patient Opinions Form of Peppermint Oil Application | 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 & Tasci, 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. | only 1st and 5th day | |
Secondary | VAS-Patient Nausea Severity Follow-up Form | 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. | 1-5 days |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06376604 -
Fasting Mimicking Diet in Chemotherapy of Gynecologic Malignancies
|
N/A | |
Completed |
NCT03753542 -
Effect of Nurse-led Education on Parent's Anxiety and Depression on Managing Side Effects of Chemotherapy
|
N/A | |
Not yet recruiting |
NCT05022628 -
Clinical Study of Radiotherapy Combined With Donafenib for Neoadjuvant Treatment of Patients With HCC With Portal Vein Carcinoma Thrombosis
|
Phase 4 | |
Completed |
NCT04207359 -
Effects of Creatine Supplementation in Breast Cancer Survivors
|
N/A | |
Active, not recruiting |
NCT04489173 -
TAS102 in Patients With ER-positive, HER2-negative Advanced Breast Cancer
|
Phase 2 | |
Completed |
NCT04173195 -
Comfort Talk (CT) During Outpatient Chemotherapy
|
N/A | |
Recruiting |
NCT06041477 -
Concurrently vs Sequentially Combined HAIC With Targeted and Immunotherapy in Potentially Resectable HCC
|
Phase 3 | |
Recruiting |
NCT05014399 -
Cognitive Impairment in Colorectal Cancer Patients Receiving Cytotoxic Chemotherapy
|
||
Recruiting |
NCT03275194 -
HIPEC in Ovarian Carcinoma Clinical Stage IIIC and IV During Interval Laparotomy
|
Phase 2 | |
Recruiting |
NCT04808466 -
Comparative Study of Lobaplatin and Paclitaxel in Advanced Gastric Cancer Patients With D2 Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
|
Phase 2 | |
Recruiting |
NCT06421610 -
OPC5: Pressurized IntraThoracic Aerosol Chemotherapy (PITAC) in Patients With Malignant Pleural Effusion.
|
Phase 1 | |
Completed |
NCT05131490 -
Effect on Adaptation to Cancer of Mobile Application Developed for Gynecological Cancer Patients
|
N/A | |
Recruiting |
NCT06043999 -
Salvage Chemotherapy Versus Total Mesorectal Resection for Local Resection Rectal Cancer Patients
|
N/A | |
Recruiting |
NCT05515796 -
Multi-omics Sequencing in Neoadjuvant Immunotherapy of Gastrointestinal Tumors
|
Phase 2 | |
Not yet recruiting |
NCT04845490 -
Comparative Study of Mitomycin and Lobaplatin in Advanced Colorectal Cancer Patients With Radical Surgery Combined With Hyperthermic Intraperitoneal Chemotherapy
|
Phase 2 | |
Recruiting |
NCT05424692 -
Drug Sensitivity Detection of Micro Tumor (PTC) to Guide Postoperative Adjuvant Treatment Strategy of Colorectal Cancer
|
N/A | |
Recruiting |
NCT05992337 -
New Biomarkers in the Prediction of Chemotherapy-induced Cardiotoxicity.
|
||
Recruiting |
NCT04989985 -
S-1 and Oxaliplatin (SOX) Plus Sintilimab in the Locally Advanced Esophagogastric Junction Adenocarcinoma
|
Phase 2 | |
Enrolling by invitation |
NCT04027478 -
Can Fasting Decrease the Side Effects of Chemotherapy?
|
N/A | |
Completed |
NCT04116138 -
Antisecretory Factor in Primary Glioblastoma 1
|
Phase 1/Phase 2 |