Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)

Chemotherapy-induced Nausea and Vomiting Clinical Trial

Official title:

Effects of Aromatherapy on Chemotherapy-Induced Nausea and Vomiting: A Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05319860
• Other study ID #: 20201412
• Status: Completed
• Phase: Phase 2
• Start date: August 1, 2022
• Est. completion date: April 15, 2024

Study information

• Verified date: April 2024
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: April 15, 2024
• Est. primary completion date: April 15, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 18 years of age or older

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:

1. Unable or unwilling to give informed consent

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

Related Conditions & MeSH terms

• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Vomiting

Intervention

Drug:
• 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.

Locations

Country	Name	City	State
United States	University of Miami	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Miami

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in severity of Chemotherapy-Induced Nausea and Vomiting (CINV)	Assessed by the mean score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT), which measures acute and delayed CINV across patients' chemotherapy regimens.; The MAT tool has a total score measured from zero to ten with the higher score indicating a higher level of nausea and vomiting.	Baseline, up to 12 weeks
Secondary	Change in frequency of Antiemetic Medication	Assessed by the mean score of antiemetics diary, which measures the usage frequency (date and time)	Baseline, up to 12 weeks
Secondary	Type of antiemetic medications	Participants will complete an Anti-Emetic Diary which will track their anti-emetic medications to combat nausea.	Up to 12 weeks