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Not yet recruiting 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

No phase Interventional Chemotherapy Induced Nausea and Vomiting

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Pepppermint oil inhalation, Placebo.
Who it may be relevant to
Registry conditions: Chemotherapy Induced Nausea and Vomiting. Basic parameters: 20 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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

Overview

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.

Interventions

  • Dietary supplement Pepppermint 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 chemotherapy infusion.
  • Dietary supplement Placebo
    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

Primary outcome measures

  • 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)]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Supportive care

Study locations

Pakistan · 1 center
  • Jinnah Hospital Lahore — Lahore

Identifiers

NCT: NCT06950632 · Institute of Nursing

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗