Breast Cancer
Conditions
Keywords
Inhalation Aromatherapy
Brief summary
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).
Detailed description
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.
Interventions
OTHERCarrier oil
Inhaler stick containing 2 drops of carrier oil.
OTHERAsian plant extract blend
Inhaler stick containing 2 drops of Asian plant extract blend.
Sponsors
National Cancer Centre, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
1. Aged 21 years old and above 2. Confirmed diagnosis of breast cancer of any stage 3. Scheduled to undergo radiotherapy for the first time 4. Capable of providing informed consent
Exclusion criteria
1. Physically or mentally incapable of providing verbal/written consent 2. Known or suspected hypersensitivity/allergy to essential oils or any components of the formulations 3. Airway hypersensitivity to fragrances, paint fumes or turpentine 4. Taking medications for anxiety (e.g. benzodiazepines) before radiotherapy 5. Pregnant, breastfeeding, or intending to conceive during study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The impact of Inhalation Aromatherapy Intervention on Distress. | 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). |
| The impact of Inhalation Aromatherapy Intervention on Anxiety. | 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. |
| The impact of Inhalation Aromatherapy Intervention on Cortisol (stress hormones). | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The impact of Inhalation Aromatherapy Intervention on pulse rate. | 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. |
| The safety outcomes associated with Inhalation Aromatherapy Intervention. | After 20 minutes of Aromatherapy Intervention (on RT day). | Incidence and severity of adverse events (AEs) and serious adverse events (SAEs). |
| The impact of Inhalation Aromatherapy Intervention on blood pressure. | 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. |
Countries
Singapore
Contacts
CONTACTDr. Fuh-Yong Wong, MBBS, FRCR
PRINCIPAL_INVESTIGATORDr. Fuh-Yong Wong, MBBS, FRCR
National Cancer Centre, Singapore
Outcome results
None listed