Breast CancerNCT06766058
Evaluating the Effectiveness of Aromatherapy for Alleviating Distress in Breast Cancer Patients Before Radiotherapy.
A study testing Carrier oil and Asian plant extract blend in people with Breast Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 99 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Carrier oil and Asian plant extract blend
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Oct 2024to 1 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 21 years old and above
- Confirmed diagnosis of breast cancer of any stage
- Scheduled to undergo radiotherapy for the first time
- Capable of providing informed consent
Who cannot join
- Physically or mentally incapable of providing verbal/written consent
- Known or suspected hypersensitivity/allergy to essential oils or any components of the formulations
- Airway hypersensitivity to fragrances, paint fumes or turpentine
- Taking medications for anxiety (e.g. benzodiazepines) before radiotherapy
- Pregnant, breastfeeding, or intending to conceive during study period
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore1 site, 1 recruiting
- Recruiting
National Cancer Centre Singapore
Singapore, 168583
Dr. Fuh-Yong Wong, MBBS, FRCR, +65 63061110, wong.fuh.yong@singhealth.com.sg
About this study
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).
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Carrier oil, Asian plant extract blend
- Keywords
- Inhalation Aromatherapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carrier oilOther
Inhaler stick containing 2 drops of carrier oil.
Asian plant extract blendOther
Inhaler stick containing 2 drops of Asian plant extract blend.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Not described Receives: Other: Carrier oil |
| Intervention Group | Experimental | Not described Receives: Other: Asian plant extract blend |
What is being measured
The primary outcome is the main question the study is designed to answer.
The impact of Inhalation Aromatherapy Intervention on Distress.
Changes of Distress Score (Distress Score from a scale of 0 - 10).
Measured: 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.
Measured: 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.
Measured: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
Secondary outcomes (3)
The impact of Inhalation Aromatherapy Intervention on blood pressure.
Change of blood pressure (in mmHg) between Before Intervention and After Intervention.
Measured: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
The impact of Inhalation Aromatherapy Intervention on pulse rate.
Change of pulse rate (in bpm) between Before Intervention and After Intervention.
Measured: 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).
Measured: After 20 minutes of Aromatherapy Intervention (on RT day).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start22 Oct 2024
- Primary completion1 Jun 2027 (estimated)
- Study completion1 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Fuh-Yong Wong, MBBS, FRCR, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06766058
- Sponsor's protocol ID
- ASTER 2
- Status last verified
- May 2026
- First submitted
- 22 Dec 2024
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Aromatherapy for Alleviating Distress in Breast Cancer Patients Before Radiotherapy.
- ClinicalTrials.gov ID
- NCT06766058
- Acronym / sponsor ID
- ASTER 2
- Conditions
- Breast Cancer
- Keywords
- Inhalation Aromatherapy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 1 Jun 2027 (estimated)
- Study completion
- 1 Jun 2027 (estimated)
- First posted
- 9 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Carrier oil |
| Intervention Group | Experimental | Other: Asian plant extract blend |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 21 years old and above
- Confirmed diagnosis of breast cancer of any stage
- Scheduled to undergo radiotherapy for the first time
- Capable of providing informed consent
Key exclusion criteria (5 listed)
- Physically or mentally incapable of providing verbal/written consent
- Known or suspected hypersensitivity/allergy to essential oils or any components of the formulations
- Airway hypersensitivity to fragrances, paint fumes or turpentine
- Taking medications for anxiety (e.g. benzodiazepines) before radiotherapy
- Pregnant, breastfeeding, or intending to conceive during study period
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carrier oilInhaler stick containing 2 drops of carrier oil. | Other | Control Group |
| Asian plant extract blendInhaler stick containing 2 drops of Asian plant extract blend. | Other | Intervention Group |
Primary outcome
The impact of Inhalation Aromatherapy Intervention on Distress.
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).
The impact of Inhalation Aromatherapy Intervention on Anxiety.
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.
The impact of Inhalation Aromatherapy Intervention on Cortisol (stress hormones).
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.
3 secondary outcomes
The impact of Inhalation Aromatherapy Intervention on blood pressure.
Time frame: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
The impact of Inhalation Aromatherapy Intervention on pulse rate.
Time frame: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
The safety outcomes associated with Inhalation Aromatherapy Intervention.
Time frame: After 20 minutes of Aromatherapy Intervention (on RT day).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Fuh-Yong Wong, MBBS, FRCR principal investigator
National Cancer Centre, Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carrier oil and Asian plant extract blend in people with Breast Cancer, run by National Cancer Centre, Singapore at 1 site in Singapore.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Fuh-Yong Wong, MBBS, FRCR (+65 63061110, wong.fuh.yong@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The impact of Inhalation Aromatherapy Intervention on Distress. (time frame: Baseline (on CT Simulation Day), Before Intervention (on RT day), and After 20 minutes of Aromatherapy Intervention (on RT day).). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2026.