Clinical trial NCT06766058: Evaluating the Effectiveness of Aromatherapy for Alleviating Distress in Breast Cancer Patients Before Radiotherapy.
Official title: Evaluating the Effectiveness of Aromatherapy for Alleviating Distress in Breast Cancer Patients Before Radiotherapy.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Keywords: Inhalation Aromatherapy
Lead sponsor: National Cancer Centre, Singapore
Sponsor class: OTHER
First posted: 2025-01-09
Enrollment: 300
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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

Primary outcomes:
measure: The impact of Inhalation Aromatherapy Intervention on Distress.
timeFrame: Baseline (on CT Simulation Day), Before Intervention (on RT day), and After 20 minutes of Aromatherapy Intervention (on RT day).
measure: The impact of Inhalation Aromatherapy Intervention on Anxiety.
timeFrame: Baseline (on CT Simulation Day), After 20 minutes of Aromatherapy Intervention (on RT day).
measure: The impact of Inhalation Aromatherapy Intervention on Cortisol (stress hormones).
timeFrame: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
Secondary outcomes:
measure: The impact of Inhalation Aromatherapy Intervention on blood pressure.
timeFrame: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
measure: The impact of Inhalation Aromatherapy Intervention on pulse rate.
timeFrame: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).
measure: The safety outcomes associated with Inhalation Aromatherapy Intervention.
timeFrame: After 20 minutes of Aromatherapy Intervention (on RT day).
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: National Cancer Centre Singapore
Study officials:
affiliation: National Cancer Centre, Singapore
name: Dr. Fuh-Yong Wong, MBBS, FRCR
role: PRINCIPAL_INVESTIGATOR
References: