Effects of Aromatherapy on Chemotherapy-Induced Nausea and Vomiting: A Control Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- University of Miami
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Acute and Delayed Chemotherapy-Induced Nausea. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.
Study Overview
Brief Summary
The purpose of this study is to evaluate the use of aromatherapy to reduce nausea, vomiting, and the use of anti-emetic in cancer survivors undergoing moderate to highly emetogenic chemotherapy regimens.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years of age or older
- •Able to read and speak English or Spanish
- •Able to and willing to give informed consent
- •Currently undergoing moderate and high emetogenic chemotherapy (adjuvant or neoadjuvant)
- •Receiving three or more remaining cycles of chemotherapy
- •Symptoms of nausea or vomiting after the first chemotherapy infusion
Exclusion Criteria
- •Unable or unwilling to give informed consent
- •Sensitivity to essential oils*
- •Olfactory disorders
- •Receiving chemotherapy for the first time
- •Undergoing low emetogenic chemotherapy regimens
- •Patients with hormone-sensitive cancers
- •Timely request of treating provider
Arms & Interventions
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.
Intervention: Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV) (Drug)
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).
Intervention: Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV) (Drug)
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).
Intervention: Aromatherapy Care (Drug)
Outcomes
Primary Outcomes
Acute and Delayed Chemotherapy-Induced Nausea. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.
Time Frame: 24 hours and 2 to 4 days post chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.
Assessed by the mean/average score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT). The scores were averaged across three visits to generate the reported values. The Antiemesis (MAT) tool is a user-friendly and reliable tool designed to measure acute and delayed Chemotherapy-Induced Nausea \& Vomiting across patients' entire chemotherapy regimens. The acute phase is during the first 24 hours after receiving chemotherapy. The delayed phase is 2 to 4 days after chemotherapy treatment. The MAT tool assessment has a total score of 0-10 (how much nausea did you have over this period), with the higher scores indicating a higher level of nausea. The completed self-reported instruments were collected on study visits 1, 2, and 3, following their scheduled outpatient chemotherapy sessions. The participants' study visits 1, 2, and 3 schedules are based on their prescribed chemotherapy regimen duration, ranging from every two to four weeks for up to 12 weeks.
Acute and Delayed Chemotherapy-Induced Vomiting. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.
Time Frame: 24 hours and 2 to 4 days post chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.
Assessed by the mean/average score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT). The MAT measures acute and delayed Chemotherapy-Induced vomiting (CINV) across patients' chemotherapy regimens using the question(s), "In the 24 hours since chemotherapy, did you have any vomiting?" and "Did you vomit 24 hours or more after chemotherapy?" respectively. Response options for both questions are a dichotomized Yes/No option. The percentage of participants who responded in the affirmative "Yes" were averaged with a score (ranging from 0-100%). The scores were averaged across three visits to generate the reported values. The completed self-reported instruments were collected on study visits 1, 2, and 3, following their scheduled outpatient chemotherapy sessions. The participants' study visits 1, 2, and 3 schedules are based on their prescribed chemotherapy regimen duration, ranging from every two to four weeks for up to 12 weeks.
Secondary Outcomes
- Change in Frequency of Antiemetic Medication Usage. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.(Daily post-chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.)
Investigators
Debbie Anglade, PhD, MSN, RN
Assistant Professor of Clinical
University of Miami