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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04116697
Other study ID # E-19-773
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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