- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06950632
This Study Will Investigate the Effectiveness of Peppermint Oil Inhalation in Reducing the Intensity and Frequency of Acute Nausea and Vomiting Among Cancer Patients Undergoing Chemotherapy. Chemotherapy-induced Nausea and Vomiting (CINV) Are Among the Most Distressing Side Effects Experienced by pa
April 22, 2025 updated by: QURAT-UL-AIN, University of Health Sciences Lahore
Effect of Peppermint Oil Inhalation on Intensity and Frequency of Acute Nausea and Vomiting in Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial
Cancer is a major cause of death and disability worldwide and in South Asian countries.
Cancer treatment options include chemotherapy, radiation therapy, surgery, and adjuvant therapy (Additional treatments after primary cancer treatment such as surgery, radiation, or chemotherapy are used to lower the chance of cancer recurrence or remove any remaining cancer cells).
Chemotherapy poses serious adverse effects, including fatigue, hair loss, skin irritation, loss of appetite, change in bowel habits, weakened immune system, dry mouth, peripheral neuropathy, nausea and vomiting.
Chemotherapy-induced nausea and vomiting cause fluid-electrolyte imbalance, dehydration, weight loss and physiological consequences due to inadequate medication absorption or compromised kidney clearance.
Although anti-emetic drugs are given to reduce CINV but these drugs pose some serious adverse effects including heartburn, insomnia, headache, dizziness, constipation/diarrhea, loss of muscle control, pharyngeal itching, dry mouth and also increases economic burden on the patient and his/her family.
The limited and hazardous side effects of these medications have led to a shift towards non-pharmacological and home remedies.
Using natural remedies is a simple and low-risk measure in this regard.
This study aims to evaluate the effects of peppermint oil inhalation on the intensity and frequency of Chemotherapy induced acute nausea and vomiting among cancer patients undergoing chemotherapy.
A randomized controlled trial will be conducted using non-probability convenience sampling, followed by random assignment to intervention and control groups.
The target population comprises patients receiving chemotherapy at the outpatient oncology department of Jinnah Hospital, Lahore.
A total of 106 patients will be enrolled.
The intervention group will receive peppermint oil inhalation, while the control group will receive a placebo.
Descriptive statistics (frequency, percentage, mean, and standard deviation) will be used to summarize participant's characteristics.
Chi-square test will be applied to compare demographic variables (e.g., age, gender, marital status, education, occupation, and RINV categories) between groups.
An independent t-test will be used to compare the mean RINV scores post-intervention between intervention and control group.
A p-value of <0.05 will be considered statistically significant.
It is anticipated that peppermint oil inhalation will significantly reduce the severity and frequency of Chemotherapy induced acute nausea and vomiting.
If effective, this complementary intervention could offer a low-cost, safe alternative to supplement standard anti-emetic therapies, potentially easing the financial and physiological burden associated with pharmacological treatments.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
106
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Qurat-Ul-Ain imran Assistant Nursing Instructor, MS Nursing
- Phone Number: 0092 3136938839
- Email: Qurat259@gmail.com
Study Contact Backup
- Name: Muhammad Imran Ramzan, BA
- Phone Number: 0092 3057551645
- Email: www.imranch451@gmail.com
Study Locations
-
-
Punjab
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Lahore, Punjab, Pakistan, 54550
- Jinnah Hospital Lahore
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
• Participants undergoing chemotherapy in the outpatient oncology department of Jinnah Hospital Lahore.
- Participants ages 20-50 years.
- Participants of Both genders' male and female.
- Participants who have undergone under one cycle of chemotherapy.
- Participants who can understand and comprehend Urdu and Punjabi language
Exclusion Criteria:
- Participants who are allergic to peppermint products.
- Participants who have any psychiatric illness.
- Participants diagnosed with any respiratory illness.
- Participants who have vomiting due to any ailment other than chemotherapy.
- Participants with Gastro-intestinal and Hepatobiliary Tumors.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Peppermint oil inhalation
Participants in the experimental group will inhale five drops of 100% pure peppermint essential oil placed on a cotton ball inside a container for ten minutes before each chemotherapy session and every two hours during the infusion
|
Participants in the experimental group will inhale five drops of 100% pure peppermint essential oil placed on a cotton ball inside a container for ten minutes before each chemotherapy session and every two hours during the chemotherapy infusion.
|
|
Sham Comparator: Control group
The control group will inhale five drops of distilled water placed on a cotton ball inside a container for ten minutes before each chemotherapy session and every two hours during the infusion
|
The control group will follow the same procedure using five drops of distilled water placed on a cotton ball inside a container for ten minutes before each chemotherapy session and every two hours during the infusion
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Effect of Peppermint Oil Inhalation on the Intensity and Frequency of Acute Nausea and Vomiting Measured by RINV Scale
Time Frame: Within 24 hours after chemotherapy (acute phase)
|
The primary outcome is the change in the intensity and frequency of acute nausea and vomiting, assessed by the Rhodes Index of Nausea, Vomiting, and Retching (RINV) Scale, within 24 hours following chemotherapy.
Comparison of mean RINV scores will be made between the experimental (peppermint oil inhalation) group and the control group.
|
Within 24 hours after chemotherapy (acute phase)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Estimated)
October 20, 2025
Primary Completion (Estimated)
March 31, 2026
Study Completion (Estimated)
March 31, 2026
Study Registration Dates
First Submitted
April 22, 2025
First Submitted That Met QC Criteria
April 22, 2025
First Posted (Actual)
April 30, 2025
Study Record Updates
Last Update Posted (Actual)
April 30, 2025
Last Update Submitted That Met QC Criteria
April 22, 2025
Last Verified
April 1, 2025
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Institute of Nursing
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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