Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)
NCT ID: NCT05319860
Last Updated: 2025-04-17
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
100 participants
INTERVENTIONAL
2022-08-01
2024-04-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard of Care With No Study Intervention
Participants will receive standard medical care, consisting of antiemetic medicine at the first sign of Chemotherapy-Induced Nausea and Vomiting (CINV) on a schedule as prescribed by the healthcare provider.
Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)
Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.
Standard of Care With Study Intervention
Participants will receive an aromatherapy inhaler for complementary in addition to their standard of care antiemetic medication for Chemotherapy-Induced Nausea and Vomiting (CINV).
Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)
Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.
Aromatherapy Care
An aromatherapy inhaler provided for use as needed after chemotherapy regimen given for up to 12 weeks. One normal inhale is equal to one dose of aromatherapy. Participants can use the aromatherapy as often as needed.
Interventions
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Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)
Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.
Aromatherapy Care
An aromatherapy inhaler provided for use as needed after chemotherapy regimen given for up to 12 weeks. One normal inhale is equal to one dose of aromatherapy. Participants can use the aromatherapy as often as needed.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Able to read and speak English or Spanish
3. Able to and willing to give informed consent
4. Currently undergoing moderate and high emetogenic chemotherapy (adjuvant or neoadjuvant)
5. Receiving three or more remaining cycles of chemotherapy
6. Symptoms of nausea or vomiting after the first chemotherapy infusion
Exclusion Criteria
2. Sensitivity to essential oils\*
3. Olfactory disorders
4. Receiving chemotherapy for the first time
5. Undergoing low emetogenic chemotherapy regimens
6. Patients with hormone-sensitive cancers
7. Timely request of treating provider
18 Years
ALL
No
Sponsors
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University of Miami
OTHER
Responsible Party
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Debbie Anglade, PhD, MSN, RN
Assistant Professor of Clinical
Principal Investigators
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Debbie Anglade, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Miami
Locations
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University of Miami
Miami, Florida, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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20201412
Identifier Type: -
Identifier Source: org_study_id
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