A Randomized Controlled Trial to Evaluate the Efficacy of Acupuncture Versus Aromatherapy as Treatments to Lessen Nausea, Vomiting and Anxiety Associated With Adriamycin and Cytoxan

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to explore the effectiveness of using acupuncture versus aromatherapy, in conjunction with standard of care anti-emetics, to decrease chemotherapy induced nausea, vomiting, and anxiety in breast cancer patients undergoing Adriamycin and Cytoxan. This study also aims to determine if aromatherapy and anti-emetics is more effective than acupuncture and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan and if acupuncture and anti-emetics is more effective than aromatherapy and anti-emetics in treating nausea, vomiting, and anxiety in patients receiving Adriamycin and Cytoxan.

Official Title
-----------------
A Randomized Controlled Trial to Evaluate the Efficacy of Acupuncture Versus Aromatherapy as Treatments to Lessen Nausea, Vomiting and Anxiety Associated With Adriamycin and Cytoxan

Conditions
-----------------
Nausea, Anxiety, Vomiting

Intervention / Treatment
-----------------
* Other: Acupuncture
* Other: Aromatherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
i) Inclusion At least 18 years of age on the day of signing informed consent Patient has a diagnosis of breast cancer Patient is planned to start Adriamycin and Cytoxan chemotherapy ii) Exclusion Patients who are unable to adhere to the protocol or treatment schedule Patients who have a concurrent illness or take medication that induces nausea independent of chemotherapy Patients undergoing radiotherapy or hormone therapy during chemotherapy treatments Patients who have a sensitive and/or poor sense of smell Patients who are allergic to essential oils, specifically peppermint, ginger, and/or lavender Patients who are already using essential oils or acupuncture for symptom management and are unwilling to stop while participating in this study Patients who are afraid of or unwilling to receive acupuncture stimulation Patients who are allergic to stainless steel needles Thrombocytopenia (Platelets < 20,000) Patients who have received aromatherapy and/or acupuncture treatment within 1 week of starting treatment on this study

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

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Experimental: Acupuncture with Anti-Emetics<br> | Other: Acupuncture<br>* Acupuncture is a form of alternative medicine in which thin needles are inserted into the body.<br>|
| Experimental: Aromatherapy with Anti-Emetics<br> | Other: Aromatherapy<br>* Aromatherapy is a form of alternative medicine in which you will inhale aromatic plant extracts and essential oils.<br>|
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in Nausea | Patients will complete an Edmonton Symptom Assessment Scale. Patients will rate their level of nausea from 0-10 with 10 being the worst possible nausea. Patients will also complete a symptom diary where they will track their level of nausea and how often they are nauseous. Patients will also complete an Anti-Emetic Diary which will track how often they are taking their anti-emetic medications to combat nausea. | 45 days | 
| improvement in anxiety | Patients will complete an Edmonton Symptom Assessment Scale. Patients will rate their level of anxiety from 0-10 with 10 being the worst possible anxiety. Patients will also complete a symptom diary where they will track their level of anxiety and how often they are anxious. | 45 days | 
| improvement in vomiting | Patients will complete a symptom diary where they will track how often they vomit. Patients will also complete an Anti-Emetic Diary which will track how often they are taking their anti-emetic medications to combat vomiting. | 45 days |