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
Official title: Effect of Peppermint Oil Inhalation on Intensity and Frequency of Acute Nausea and Vomiting in Cancer Patients Receiving Chemotherapy: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Chemotherapy Induced Nausea and Vomiting
Keywords: Peppermint oil inhalation
Lead sponsor: University of Health Sciences Lahore
Sponsor class: OTHER
First posted: 2025-04-30
Enrollment: 106
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Effect of Peppermint Oil Inhalation on the Intensity and Frequency of Acute Nausea and Vomiting Measured by RINV Scale
timeFrame: Within 24 hours after chemotherapy (acute phase)
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Jinnah Hospital Lahore
state: Punjab
Study officials:
References: