NCT07318779

Brief Summary

The aim of this study is to evaluate the effect of inhaled cardamom oil on chemotherapy-related nausea, vomiting, and food intake and to compare these effects with those of inhaled peppermint oil.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
39

participants targeted

Target at below P25 for not_applicable cancer

Timeline
6mo left

Started Jan 2026

Shorter than P25 for not_applicable cancer

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

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Study Timeline

Key milestones and dates

Study Progress42%
Jan 2026Nov 2026

First Submitted

Initial submission to the registry

November 19, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

January 1, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 6, 2026

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2026

Last Updated

January 6, 2026

Status Verified

December 1, 2025

Enrollment Period

6 months

First QC Date

November 19, 2025

Last Update Submit

December 20, 2025

Conditions

Keywords

AromatherapyChemotherapyNauseaVomitingFood Intake

Outcome Measures

Primary Outcomes (7)

  • Chemotherapy-Related Nausea-Vomiting and Retching

    The Rhodes Index of Nausea, Vomiting and Retching (INVR) was developed by Rhodes and McDaniel in 1999 to assess nausea, vomiting, retching, and related distress experienced within the last 12 hours, particularly after chemotherapy. The scale consists of 8 items rated on a Likert-type scale, where 0 indicates minimal distress and 4 indicates severe distress. Items 1, 3, 6, and 7 are reverse-scored. The INVR includes three subdimensions: symptom experience, symptom occurrence, and symptom distress. The original scale demonstrated high internal consistency (Cronbach's alpha = 0.98; subscales = 0.83-0.99).

    five consecutive days.

  • Food Intake

    Food Consumption Form: The 24-hour dietary recall method is used to record food intake. In this study, patients record all foods and beverages consumed over five consecutive days. Portions are documented using household measures such as cups, glasses, mugs, and spoons.

    five consecutive days.

  • Chemotherapy-Related Nausea

    Visual Analog Scale (VAS): The severity of nausea will be assessed using a 100-mm Visual Analog Scale (VAS), where the left end represents "no nausea" and the right end represents "severe nausea." A score \<5 mm is defined as no nausea, and a 10-mm difference is typically considered clinically significant.

    five consecutive days.

  • Food Frequency Form

    This form identifies the food groups consumed by the patient over the five-day period. It verifies the information recorded in the food consumption form and provides insight into the patient's dietary patterns. The food frequency method is commonly used to assess relationships between diet and disease risk.

    five consecutive days.

  • Anthropometric Measurements1

    Body mass index (BMI) is calculated by dividing weight in kilograms by height in meters squared (kg/height²).

    Measurements will be taken twice, on the first and fifth days.

  • Anthropometric Measurements2

    Skinfold thickness measurements are taken using calipers and are used to rank individuals in terms of relative total "fatness" or to assess subcutaneous fat in various areas of the body.

    Measurements will be taken twice, on the first and fifth days.

  • Anthropometric Measurements3

    waist and hip circumference: Using a tape measure, measure around the narrowest part of the waist, just above the belly button. This is the waist circumference. Measure around the widest part of the hips. This is the hip circumference.

    Measurements will be taken twice, on the first and fifth days.

Study Arms (3)

peppermint oil

EXPERIMENTAL

Thirty minutes before the chemotherapy session begins, one drop of essential oil will be applied to a piece of gauze. The gauze will then be attached to the patient's collar with a safety pin, positioned 20 cm away from the patient's nose. This procedure will be performed three times a day for five consecutive days.

Other: Peppermint Oil

cardamom oil

ACTIVE COMPARATOR

Thirty minutes before the chemotherapy session begins, one drop of essential oil will be applied to a piece of gauze. The gauze will then be attached to the patient's collar with a safety pin, positioned 20 cm away from the patient's nose. This procedure will be performed three times a day for five consecutive days.

Other: cardomom oil

sweet almond oil

SHAM COMPARATOR

Thirty minutes before the chemotherapy session begins, one drop of essential oil will be applied to a piece of gauze. The gauze will then be attached to the patient's collar with a safety pin, positioned 20 cm away from the patient's nose. This procedure will be performed three times a day for five consecutive days.

Other: sweet almond oil

Interventions

Thirty minutes before the chemotherapy session begins, one drop of essential oil will be applied to a piece of gauze. The gauze will then be attached to the patient's collar with a safety pin, positioned 20 cm away from the patient's nose. This procedure will be performed three times a day for five consecutive days.

peppermint oil

Thirty minutes before the chemotherapy session begins, one drop of essential oil will be applied to a piece of gauze. The gauze will then be attached to the patient's collar with a safety pin, positioned 20 cm away from the patient's nose. This procedure will be performed three times a day for five consecutive days.

cardamom oil

Thirty minutes before the chemotherapy session begins, one drop of essential oil will be applied to a piece of gauze. The gauze will then be attached to the patient's collar with a safety pin, positioned 20 cm away from the patient's nose. This procedure will be performed three times a day for five consecutive days.

sweet almond oil

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Volunteered to participate in the study,
  • Received at least one cycle and are continuing to receive either Adriamycin-cyclophosphamide or Adriamycin-cyclophosphamide-fluorouracil chemotherapy protocols,
  • Have an intact sense of smell.

You may not qualify if:

  • Under 18 years of age,
  • Have neurocognitive impairment and are unable to answer the questionnaire,
  • Have a condition that may trigger nausea and vomiting, such as vertigo or motion sickness,
  • Have a chronic respiratory disease (with a history of asthma or other reactive airway diseases),
  • Have a known history of allergies,
  • Have a history of prolonged or excessive alcohol use,
  • Use any scented products during the intervention period,
  • Receive other complementary therapies for nausea and vomiting.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eskişehir City Hospital

Eskişehir, Turkey (Türkiye)

Location

MeSH Terms

Conditions

NeoplasmsNauseaVomiting

Interventions

peppermint oilalmond oil

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Semanur Bilgiç, Research Asisstant

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Research Assistant

Study Record Dates

First Submitted

November 19, 2025

First Posted

January 6, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

November 1, 2026

Last Updated

January 6, 2026

Record last verified: 2025-12

Locations