NCT06950632

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
106

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 22, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 30, 2025

Completed
6 months until next milestone

Study Start

First participant enrolled

October 20, 2025

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2026

Completed
Last Updated

April 30, 2025

Status Verified

April 1, 2025

Enrollment Period

5 months

First QC Date

April 22, 2025

Last Update Submit

April 22, 2025

Conditions

Keywords

Peppermint oil inhalation

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

EXPERIMENTAL

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

Dietary Supplement: Pepppermint oil inhalation

Control group

SHAM COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Pepppermint oil inhalationDIETARY_SUPPLEMENT

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.

Peppermint oil inhalation
PlaceboDIETARY_SUPPLEMENT

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

Control group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

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

Location

Related Links

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Central Study Contacts

Qurat-Ul-Ain imran Assistant Nursing Instructor, MS Nursing

CONTACT

Muhammad Imran Ramzan, BA

CONTACT

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

Locations