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Aromatherapy for Nausea and Vomiting
Phase 2
Waitlist Available
Led By Debbie Anglade, PhD
Research Sponsored by University of Miami
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Symptoms of nausea or vomiting after the first chemotherapy infusion
Receiving three or more remaining cycles of chemotherapy
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 12 weeks
Awards & highlights
Study Summary
This trial will study whether aromatherapy can help reduce chemotherapy side effects like nausea and vomiting.
Who is the study for?
This trial is for cancer survivors over 18 who can understand English or Spanish, are undergoing moderate to high emetogenic chemotherapy with at least three cycles left, and have experienced nausea or vomiting after their first infusion. It's not for those with hormone-sensitive cancers, olfactory disorders, sensitivity to essential oils, receiving their first chemo cycle, or on low emetogenic regimens.Check my eligibility
What is being tested?
The study compares the effectiveness of aromatherapy versus standard care in reducing nausea and vomiting caused by certain chemotherapy treatments. Participants will receive either the usual anti-nausea medication along with aromatherapy or just the standard treatment without aromatherapy.See study design
What are the potential side effects?
While standard anti-nausea medications can cause headaches, constipation, and dizziness; aromatherapy may lead to allergic reactions or skin irritation in some individuals sensitive to essential oils.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I experienced nausea or vomiting after my first chemotherapy session.
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I have three or more chemotherapy sessions left.
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I am receiving chemotherapy that often causes vomiting.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in severity of Chemotherapy-Induced Nausea and Vomiting (CINV)
Secondary outcome measures
Change in frequency of Antiemetic Medication
Type of antiemetic medications
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Standard of Care With Study InterventionExperimental Treatment2 Interventions
Participants will receive an aromatherapy inhaler for complementary in addition to their standard of care antiemetic medication for Chemotherapy-Induced Nausea and Vomiting (CINV).
Group II: Standard of Care With No Study InterventionActive Control1 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.
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Who is running the clinical trial?
University of MiamiLead Sponsor
899 Previous Clinical Trials
409,582 Total Patients Enrolled
Debbie Anglade, PhDPrincipal InvestigatorUniversity of Miami
1 Previous Clinical Trials
16 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have three or more chemotherapy sessions left.I have a problem with my sense of smell.I can read and speak English or Spanish.My cancer responds to hormone therapy.I experienced nausea or vomiting after my first chemotherapy session.I am on a chemotherapy plan that is unlikely to cause vomiting.I am receiving chemotherapy that often causes vomiting.I am starting chemotherapy for the first time.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Standard of Care With No Study Intervention
- Group 2: Standard of Care With Study Intervention
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What possible risks are associated with using aromatherapy treatments?
"Aromatherapy Care received a score of 2 because, while there is some evidence that it is safe, none exists to support that it is effective."
Answered by AI
Are there any patients that qualify for this research program at the moment?
"Unfortunately, this particular trial is not recruiting patients as of right now. According to the latest update on clinicaltrials.gov (8/31/2022), this study was initially posted on 8/1/2022. Although this specific trial may not be seeking candidates, there are 120 other trials that are currently looking for patients."
Answered by AI
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