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

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.

Study Overview

• Status: Completed
• Conditions: Nausea; Vomiting; Anxiety
• Intervention / Treatment: Other: Acupuncture; Other: Aromatherapy

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New Jersey
    • Englewood, New Jersey, United States, 07631
      • Englewood Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Group
Experimental: Acupuncture with Anti-Emetics	Other: Acupuncture; Acupuncture is a form of alternative medicine in which thin needles are inserted into the body.
Experimental: Aromatherapy with Anti-Emetics	Other: Aromatherapy; Aromatherapy is a form of alternative medicine in which you will inhale aromatic plant extracts and essential oils.

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

Collaborators and Investigators

• Sponsor: Englewood Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): October 23, 2019
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: October 3, 2019
• First Submitted That Met QC Criteria: October 3, 2019
• First Posted (Actual): October 7, 2019

Study Record Updates

• Last Update Posted (Actual): April 13, 2025
• Last Update Submitted That Met QC Criteria: April 11, 2025
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Signs and Symptoms, Digestive; Anxiety Disorders; Nausea; Vomiting
• Other Study ID Numbers: E-19-773

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No