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

ConditionBreast Cancer
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age21-99
SponsorNational Cancer Centre, Singapore

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Carrier oil

    Other intervention

    Inhaler stick containing 2 drops of carrier oil.

  • Asian plant extract blend

    Other intervention

    Inhaler stick containing 2 drops of Asian plant extract blend.

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: Control GroupPlacebo comparator 1 intervention
Group B: Intervention GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

The impact of Inhalation Aromatherapy Intervention on Distress.

Changes of Distress Score (Distress Score from a scale of 0 - 10).

Time frame
Baseline (on CT Simulation Day), Before Intervention (on RT day), and After 20 minutes of Aromatherapy Intervention (on RT day).
2

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.

Time frame
Baseline (on CT Simulation Day), After 20 minutes of Aromatherapy Intervention (on RT day).
3

The impact of Inhalation Aromatherapy Intervention on Cortisol (stress hormones).

Change of Cortisol Levels in nmol/L between Before Intervention and After Intervention.

Time frame
Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).

Secondary outcomes

1

The impact of Inhalation Aromatherapy Intervention on blood pressure.

Change of blood pressure (in mmHg) between Before Intervention and After Intervention.

Time frame
Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
2

The impact of Inhalation Aromatherapy Intervention on pulse rate.

Change of pulse rate (in bpm) between Before Intervention and After Intervention.

Time frame
Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
3

The safety outcomes associated with Inhalation Aromatherapy Intervention.

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

Time frame
After 20 minutes of Aromatherapy Intervention (on RT day).

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Cancer Centre, Singapore

Lead sponsor

Source ClinicalTrials.gov
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