NCT06766058

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).

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
12mo left

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress63%
Oct 2024Jun 2027

Study Start

First participant enrolled

October 22, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 22, 2024

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 9, 2025

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

May 15, 2026

Status Verified

May 1, 2026

Enrollment Period

2.6 years

First QC Date

December 22, 2024

Last Update Submit

May 12, 2026

Conditions

Breast Cancer

Keywords

Inhalation Aromatherapy

Outcome Measures

Primary Outcomes (3)

  • The impact of Inhalation Aromatherapy Intervention on Distress.

    Changes of Distress Score (Distress Score from a scale of 0 - 10).

    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.

    Change of General Anxiety Disorder Score (GAD-7 Score from a scale of 0 - 21) between Baseline and After Intervention.

    Baseline (on CT Simulation Day), After 20 minutes of Aromatherapy Intervention (on RT day).

  • The impact of Inhalation Aromatherapy Intervention on Cortisol (stress hormones).

    Change of Cortisol Levels in nmol/L between Before Intervention and After Intervention.

    Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).

Secondary Outcomes (3)

  • The impact of Inhalation Aromatherapy Intervention on blood pressure.

    Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).

  • The impact of Inhalation Aromatherapy Intervention on pulse rate.

    Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).

  • The safety outcomes associated with Inhalation Aromatherapy Intervention.

    After 20 minutes of Aromatherapy Intervention (on RT day).

Study Arms (2)

Control Group

PLACEBO COMPARATOR
Other: Carrier oil

Intervention Group

EXPERIMENTAL
Other: Asian plant extract blend

Interventions

Carrier oilOTHER

Inhaler stick containing 2 drops of carrier oil.

Control Group
Asian plant extract blendOTHER

Inhaler stick containing 2 drops of Asian plant extract blend.

Intervention Group

Eligibility Criteria

Age21 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Cancer Centre Singapore

Singapore, 168583, Singapore

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Carrier State

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic MethodsPublic HealthEnvironment and Public Health

Study Officials

  • Dr. Fuh-Yong Wong, MBBS, FRCR

    National Cancer Centre, Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr. Fuh-Yong Wong, MBBS, FRCR

CONTACT

+65 63061110wong.fuh.yong@singhealth.com.sg

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2024

First Posted

January 9, 2025

Study Start

October 22, 2024

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Last Updated

May 15, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations

SG(1)