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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Group | Placebo Comparator |
| |
| Intervention Group | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Carrier oil | Other | Inhaler stick containing 2 drops of carrier oil. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of Inhalation Aromatherapy Intervention on Distress. | Changes of Distress Score (Distress Score from a scale of 0 - 10). | Baseline (on CT Simulation Day), Before Intervention (on RT day), and After 20 minutes of Aromatherapy Intervention (on RT day). |
| The impact of Inhalation Aromatherapy Intervention on Anxiety. | Change of General Anxiety Disorder Score (GAD-7 Score from a scale of 0 - 21) between Baseline and After Intervention. | Baseline (on CT Simulation Day), After 20 minutes of Aromatherapy Intervention (on RT day). |
| The impact of Inhalation Aromatherapy Intervention on Cortisol (stress hormones). | Change of Cortisol Levels in nmol/L between Before Intervention and After Intervention. | Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day). |
| Measure | Description | Time Frame |
|---|---|---|
| The impact of Inhalation Aromatherapy Intervention on blood pressure. | Change of blood pressure (in mmHg) between Before Intervention and After Intervention. | Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day). |
| The impact of Inhalation Aromatherapy Intervention on pulse rate. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dr. Fuh-Yong Wong, MBBS, FRCR | Contact | +65 63061110 | wong.fuh.yong@singhealth.com.sg |
| Name | Affiliation | Role |
|---|---|---|
| Dr. Fuh-Yong Wong, MBBS, FRCR | National Cancer Centre, Singapore | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Cancer Centre Singapore | Recruiting | Singapore | 168583 | Singapore |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D002353 | Carrier State |
| ID | Term |
|---|---|
| D004812 | Epidemiologic Methods |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
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| Asian plant extract blend |
| Other |
Inhaler stick containing 2 drops of Asian plant extract blend. |
|
Change of pulse rate (in bpm) between Before Intervention and After Intervention. |
| Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day). |
| The safety outcomes associated with Inhalation Aromatherapy Intervention. | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). | After 20 minutes of Aromatherapy Intervention (on RT day). |
| D017437 |
| Skin and Connective Tissue Diseases |