National Cancer Centre Singapore
Singapore, 168583
Location status: Recruiting
NCT Number: NCT06766058
ASTER is a multi-part study that aims to prospectively establish evidence for the implementation of aromatherapy as complementary therapy within cancer care in the Singapore context. ASTER 2 study evaluates how extracts from Asian aromatic plants with familiar aromas introduced as inhalation therapy can alleviate distress in breast cancer patients scheduled to undergo radiotherapy (RT).
Interested in participating?
Request Info21 year–99 year
Female
Interventional
Not applicable
Singapore, 168583
Location status: Recruiting
On the day of CT Simulation, a research coordinator from the team will obtain consent from the eligible patients. Patient related outcomes will be collected from the consented patients. Study team will meet the patient 2 weeks later, on the day of their first radiotherapy session. Patient will be given an hour before the radiotherapy session begin. During this time distress score will be assessed, blood pressure and pulse rate will be measured, and saliva sample be collected. Patients will then be provided with the Inhaler stick containing 2 drops of either carrier oil (placebo), or Asian plant extract blend (intervention), which will be prepared prior to the study recruitment.
Patient will be instructed to hold the inhaler stick at about 8 cm (a hand fist's distance) away from their nose, to take up to 3 sniffs. This will be repeated with every 5 minutes of interval for 20 minutes of duration. After completion of the inhalation procedure, anxiety & distress score will be assessed, blood pressure and pulse rate will be measured, and saliva sample be collected.
A total of 300 breast cancer patients scheduled to undergo radiotherapy for the first time will be recruited in a randomized double-blind, 2-arm study: 150 patients in a Placebo-Control-Group, 150 patients in the Aromatherapy-Intervention-Group.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Inhaler stick containing 2 drops of carrier oil.
Inhaler stick containing 2 drops of Asian plant extract blend.
Time frame: Baseline (on CT Simulation Day), Before Intervention (on RT day), and After 20 minutes of Aromatherapy Intervention (on RT day).
Changes of Distress Score (Distress Score from a scale of 0 - 10).
Time frame: Baseline (on CT Simulation Day), After 20 minutes of Aromatherapy Intervention (on RT day).
Change of General Anxiety Disorder Score (GAD-7 Score from a scale of 0 - 21) between Baseline and After Intervention.
Time frame: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
Change of Cortisol Levels in nmol/L between Before Intervention and After Intervention.
Time frame: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
Change of blood pressure (in mmHg) between Before Intervention and After Intervention.
Time frame: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
Change of pulse rate (in bpm) between Before Intervention and After Intervention.
Time frame: After 20 minutes of Aromatherapy Intervention (on RT day).
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
Contact information is provided by the study sponsor or research team.
National Cancer Centre, Singapore
Other
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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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