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
Effect of Peppermint Oil Inhalation on Intensity and Frequency of Acute Nausea and Vomiting in Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial
1 other identifier
interventional
106
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2025
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 22, 2025
CompletedFirst Posted
Study publicly available on registry
April 30, 2025
CompletedStudy Start
First participant enrolled
October 20, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2026
CompletedApril 30, 2025
April 1, 2025
5 months
April 22, 2025
April 22, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Effect of Peppermint Oil Inhalation on the Intensity and Frequency of Acute Nausea and Vomiting Measured by RINV Scale
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)
Study Arms (2)
Peppermint oil inhalation
EXPERIMENTALParticipants 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
Control group
SHAM COMPARATORThe 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
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Jinnah Hospital Lahore
Lahore, Punjab Province, 54550, Pakistan
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Qurat-Ul-Ain
Study Record Dates
First Submitted
April 22, 2025
First Posted
April 30, 2025
Study Start
October 20, 2025
Primary Completion
March 31, 2026
Study Completion
March 31, 2026
Last Updated
April 30, 2025
Record last verified: 2025-04