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

Not Applicable

Recruiting

• Conditions: Breast Cancer

• Registration Number: NCT06766058
• Lead Sponsor: National Cancer Centre, Singapore

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.

Study Timeline

• Study Start: 2024-10-22
• Study First Submitted: 2024-12-22
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-03
• Last Update Submitted: 2025-01-03
• Study First Posted: 2025-01-09
• Last Update Posted: 2025-01-09
• Primary Completion: 2026-10-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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).

Trial Locations

Locations (1)

National Cancer Centre Singapore; 🇸🇬 Singapore, Singapore