Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)

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.

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

Conditions
-----------------
Chemotherapy-induced Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)
* Drug: Aromatherapy Care


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard of Care With No Study Intervention<br>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. | Drug: Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)<br>* Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.<br>|
| Experimental: Standard of Care With Study Intervention<br>Participants will receive an aromatherapy inhaler for complementary in addition to their standard of care antiemetic medication for Chemotherapy-Induced Nausea and Vomiting (CINV). | Drug: Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)<br>* Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.<br>Drug: Aromatherapy Care<br>* 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.<br>* Other names: Soothing Scents QueaseEase aromatherapy inhalers;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |