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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-22

Study Completion Date

2026-10-01

Brief Summary

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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).

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Detailed Description

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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.

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Control Group

Group Type PLACEBO_COMPARATOR

Carrier oil

Intervention Type OTHER

Inhaler stick containing 2 drops of carrier oil.

Intervention Group

Group Type EXPERIMENTAL

Asian plant extract blend

Intervention Type OTHER

Inhaler stick containing 2 drops of Asian plant extract blend.

Interventions

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Carrier oil

Inhaler stick containing 2 drops of carrier oil.

Intervention Type OTHER

Asian plant extract blend

Inhaler stick containing 2 drops of Asian plant extract blend.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Maximum Eligible Age

99 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No