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

Обзор

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).

Подробное описание

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.

Вмешательства

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

Первичные конечные точки

• The impact of Inhalation Aromatherapy Intervention on Distress. [Срок оценки: 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. [Срок оценки: Baseline (on CT Simulation Day), After 20 minutes of Aromatherapy Intervention (on RT day).]
• The impact of Inhalation Aromatherapy Intervention on Cortisol (stress hormones). [Срок оценки: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).]

Вторичные конечные точки (3)

• The impact of Inhalation Aromatherapy Intervention on blood pressure. [Срок оценки: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).]
• The impact of Inhalation Aromatherapy Intervention on pulse rate. [Срок оценки: Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).]
• The safety outcomes associated with Inhalation Aromatherapy Intervention. [Срок оценки: After 20 minutes of Aromatherapy Intervention (on RT day).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Сингапур · 1 центр

• National Cancer Centre Singapore — Singapore

Идентификаторы

NCT: NCT06766058 · ASTER 2

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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