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NCT Number: NCT06766058

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

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).

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Key information

Age range

21 year–99 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

National Cancer Centre Singapore

Singapore, 168583

Location status: Recruiting

Location contact

Dr. Fuh-Yong Wong, MBBS, FRCR

CONTACT

[email protected]

+65 63061110

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Carrier oil

Other

Inhaler stick containing 2 drops of carrier oil.

Asian plant extract blend

Other

Inhaler stick containing 2 drops of Asian plant extract blend.

Primary outcomes

  1. 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).

  2. 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.

  3. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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).

Study contacts

Contact information is provided by the study sponsor or research team.

Dr. Fuh-Yong Wong, MBBS, FRCR

CONTACT

[email protected]

+65 63061110

Sponsors and collaborators

Lead sponsor

National Cancer Centre, Singapore

Other

Registry information

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Jan 9, 2025
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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