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

Anxiety Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04116697
• Other study ID #: E-19-773
• Status: Recruiting
• Phase: N/A
• Start date: October 23, 2019
• Est. completion date: December 2023

Study information

• Verified date: July 2022
• Source: Englewood Hospital and Medical Center
• Contact: Jamie Ketas
• Phone: 201-894-3418
• Email: Jamie.Ketas[@]EHMCHealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2023
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Nausea
• Vomiting

Intervention

Other:
• Acupuncture
Acupuncture is a form of alternative medicine in which thin needles are inserted into the body.
• Aromatherapy
Aromatherapy is a form of alternative medicine in which you will inhale aromatic plant extracts and essential oils.

Locations

Country	Name	City	State
United States	Englewood Health	Englewood	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Englewood Hospital and Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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