Evaluating the Effectiveness of Aromatherapy for Alleviating Distress in Breast Cancer Patients Before Radiotherapy.

May 12, 2026 updated by: National Cancer Centre, Singapore
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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention Group
Other: Asian plant extract blend
Inhaler stick containing 2 drops of Asian plant extract blend.
Placebo Comparator: Control Group
Other: Carrier oil
Inhaler stick containing 2 drops of carrier oil.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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.
Baseline (on CT Simulation Day), After 20 minutes of Aromatherapy Intervention (on RT day).
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.
Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
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.
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.
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).
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).
After 20 minutes of Aromatherapy Intervention (on RT day).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Cancer Centre, Singapore

Investigators

  • Principal Investigator: Dr. Fuh-Yong Wong, MBBS, FRCR, National Cancer Centre, Singapore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

December 22, 2024

First Submitted That Met QC Criteria

January 3, 2025

First Posted (Actual)

January 9, 2025

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 12, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ASTER 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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