Ignite Creation Date:
2025-12-25 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 10:16 PM
Study NCT ID:
NCT06766058
Status:
RECRUITING
Last Update Posted:
2025-01-09
First Post:
2024-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Evaluating the Effectiveness of Aromatherapy for Alleviating Distress in Breast Cancer Patients Before Radiotherapy.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002353', 'term': 'Carrier State'}], 'ancestors': [{'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-03', 'studyFirstSubmitDate': '2024-12-22', 'studyFirstSubmitQcDate': '2025-01-03', 'lastUpdatePostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The impact of Inhalation Aromatherapy Intervention on Distress.', 'timeFrame': 'Baseline (on CT Simulation Day), Before Intervention (on RT day), and After 20 minutes of Aromatherapy Intervention (on RT day).', 'description': 'Changes of Distress Score (Distress Score from a scale of 0 - 10).'}, {'measure': 'The impact of Inhalation Aromatherapy Intervention on Anxiety.', 'timeFrame': 'Baseline (on CT Simulation Day), After 20 minutes of Aromatherapy Intervention (on RT day).', 'description': 'Change of General Anxiety Disorder Score (GAD-7 Score from a scale of 0 - 21) between Baseline and After Intervention.'}, {'measure': 'The impact of Inhalation Aromatherapy Intervention on Cortisol (stress hormones).', 'timeFrame': 'Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).', 'description': 'Change of Cortisol Levels in nmol/L between Before Intervention and After Intervention.'}], 'secondaryOutcomes': [{'measure': 'The impact of Inhalation Aromatherapy Intervention on blood pressure.', 'timeFrame': 'Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).', 'description': 'Change of blood pressure (in mmHg) between Before Intervention and After Intervention.'}, {'measure': 'The impact of Inhalation Aromatherapy Intervention on pulse rate.', 'timeFrame': 'Before Intervention (on RT day), After 20 minutes of Aromatherapy Intervention (on RT day).', 'description': 'Change of pulse rate (in bpm) between Before Intervention and After Intervention.'}, {'measure': 'The safety outcomes associated with Inhalation Aromatherapy Intervention.', 'timeFrame': 'After 20 minutes of Aromatherapy Intervention (on RT day).', 'description': 'Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inhalation Aromatherapy'], 'conditions': ['Breast Cancer']}, 'descriptionModule': {'briefSummary': '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).', 'detailedDescription': "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.\n\nPatient 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.\n\nA 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."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Aged 21 years old and above\n2. Confirmed diagnosis of breast cancer of any stage\n3. Scheduled to undergo radiotherapy for the first time\n4. Capable of providing informed consent\n\nExclusion Criteria:\n\n1. Physically or mentally incapable of providing verbal/written consent\n2. Known or suspected hypersensitivity/allergy to essential oils or any components of the formulations\n3. Airway hypersensitivity to fragrances, paint fumes or turpentine\n4. Taking medications for anxiety (e.g. benzodiazepines) before radiotherapy\n5. Pregnant, breastfeeding, or intending to conceive during study period'}, 'identificationModule': {'nctId': 'NCT06766058', 'briefTitle': 'Evaluating the Effectiveness of Aromatherapy for Alleviating Distress in Breast Cancer Patients Before Radiotherapy.', 'organization': {'class': 'OTHER', 'fullName': 'National Cancer Centre, Singapore'}, 'officialTitle': 'Evaluating the Effectiveness of Aromatherapy for Alleviating Distress in Breast Cancer Patients Before Radiotherapy.', 'orgStudyIdInfo': {'id': 'ASTER 2'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'interventionNames': ['Other: Carrier oil']}, {'type': 'EXPERIMENTAL', 'label': 'Intervention Group', 'interventionNames': ['Other: Asian plant extract blend']}], 'interventions': [{'name': 'Carrier oil', 'type': 'OTHER', 'description': 'Inhaler stick containing 2 drops of carrier oil.', 'armGroupLabels': ['Control Group']}, {'name': 'Asian plant extract blend', 'type': 'OTHER', 'description': 'Inhaler stick containing 2 drops of Asian plant extract blend.', 'armGroupLabels': ['Intervention Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '168583', 'city': 'Singapore', 'status': 'RECRUITING', 'country': 'Singapore', 'contacts': [{'name': 'Dr. Fuh-Yong Wong, MBBS, FRCR', 'role': 'CONTACT', 'email': 'wong.fuh.yong@singhealth.com.sg', 'phone': '+65 63061110'}], 'facility': 'National Cancer Centre Singapore', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'centralContacts': [{'name': 'Dr. Fuh-Yong Wong, MBBS, FRCR', 'role': 'CONTACT', 'email': 'wong.fuh.yong@singhealth.com.sg', 'phone': '+65 63061110'}], 'overallOfficials': [{'name': 'Dr. Fuh-Yong Wong, MBBS, FRCR', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cancer Centre, Singapore'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cancer Centre, Singapore', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}