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

National Cancer Centre, Singapore

Status: Enrolling

Conditions: Breast Cancer

Treatments: Other: Asian plant extract blend; Other: Carrier oil

Study type: Interventional

Funder types: Other

Identifiers

NCT06766058

ASTER 2

Details and patient eligibility

About

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).

Full 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.

Enrollment: 300 estimated patients

Sex: Female

Ages: 21 to 99 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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300 participants in 2 patient groups, including a placebo group

Control Group

Placebo Comparator group

Treatment:

Other: Carrier oil

Intervention Group

Experimental group

Treatment:

Other: Asian plant extract blend