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Recruiting NCT06766058

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

No phase Interventional Breast Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Carrier oil, Asian plant extract blend.
Who it may be relevant to
Registry conditions: Breast Cancer. Basic parameters: 21 years — 99 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Singapore
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Other Carrier oil
    Inhaler stick containing 2 drops of carrier oil.
  • Other Asian plant extract blend
    Inhaler stick containing 2 drops of Asian plant extract blend.

Primary outcome measures

  • 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 impact of Inhalation Aromatherapy Intervention on Anxiety. [Time frame: 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).]
Secondary outcome measures (3)
  • 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).]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Singapore · 1 center
  • National Cancer Centre Singapore — Singapore

Identifiers

NCT: NCT06766058 · ASTER 2

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗