- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07318779
Effect of Cardamom and Peppermint Oils on Chemotherapy-Related Nausea-Vomiting and Food Intake
Effect of Cardamom and Peppermint Oils on Chemotherapy-Related Nausea-Vomiting and Food Intake: Randomized Controlled Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Chemotherapy is an effective treatment method used to control cancer systemically by destroying cancer cells or controlling their growth. This treatment inhibits nucleic acid synthesis, thereby preventing DNA and RNA synthesis, and has both cytotoxic and anticancer properties. However, chemotherapy also affects rapidly dividing cells, leading to undesirable side effects. Among these, nausea and vomiting are common and quality-of-life-reducing side effects that affect approximately 80% of patients undergoing chemotherapy.
The pathophysiology of nausea and vomiting is based on mechanisms such as the stimulation of the vomiting center and the chemoreceptor trigger zone, as well as the stimulation of enterochromaffin cells and vagal afferent neurons. Failure to manage these symptoms can lead to serious problems such as malnutrition, dehydration, anorexia, and fluid-electrolyte imbalance. Therefore, antiemetic drugs and various integrative methods (acupuncture, acupressure, behavioral interventions, music therapy, relaxation exercises, hypnotherapy, and aromatherapy) are used to manage nausea and vomiting.
Aromatherapy with various essential oils such as peppermint, ginger, rose, cardamom, lavender, and chamomile has been found to be effective in preventing nausea and vomiting. The effect of peppermint oil on chemotherapy-related nausea and vomiting is well-documented; however, research on cardamom oil is limited. There are few studies in the literature evaluating the effect of cardamom oil on these symptoms. 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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Semanur Bilgiç, Research Asisstant
- Phone Number: +905395966328
- Email: semanurblgc@gmail.com
Study Locations
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Eskişehir, Turkey (Türkiye)
- Eskişehir City Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 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.
|
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.
|
|
Active Comparator: 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.
|
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.
|
|
Sham Comparator: sweet almond 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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Chemotherapy-Related Nausea-Vomiting and Retching
Time Frame: five consecutive days.
|
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).
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five consecutive days.
|
|
Food Intake
Time Frame: five consecutive days.
|
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
Time Frame: five consecutive days.
|
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
Time Frame: five consecutive days.
|
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.
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five consecutive days.
|
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Anthropometric Measurements1
Time Frame: Measurements will be taken twice, on the first and fifth days.
|
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.
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|
Anthropometric Measurements2
Time Frame: Measurements will be taken twice, on the first and fifth days.
|
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
Time Frame: Measurements will be taken twice, on the first and fifth days.
|
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.
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- Chemotherapy
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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