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
- Conditions
- Chemotherapy Induced Nausea and Vomiting
- Registration Number
- NCT06950632
- Lead Sponsor
- University of Health Sciences Lahore
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 106
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• 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Effect of Peppermint Oil Inhalation on the Intensity and Frequency of Acute Nausea and Vomiting Measured by RINV Scale 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Jinnah Hospital Lahore
🇵🇰Lahore, Punjab, Pakistan