Image

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

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

Recruiting
21-99 years
Female
Phase N/A

Powered by AI

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).

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

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

Study details
    Breast Cancer

NCT06766058

National Cancer Centre, Singapore

13 January 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.