Eskişehir City Hospital
Eskişehir, Turkey (Türkiye)
NCT Number: NCT07318779
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 opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Eskişehir, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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).
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.
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.
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.
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).
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.
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.
Contact information is provided by the study sponsor or research team.
Semanur Bilgiç
Other
Effect of Cardamom and Peppermint Oils on Chemotherapy-Related Nausea-Vomiting and Food Intake: Randomized Controlled Study
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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