Back to resultsA Randomized Controlled Trial to Evaluate the Efficacy of Acupuncture Versus Aromatherapy as Treatments to Lessen Nausea, Vomiting and Anxiety Associated With Adriamycin and Cytoxan
Primary Purpose
Nausea, Vomiting, Anxiety
Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Acupuncture
Aromatherapy
Sponsored by
About this trial
This is an interventional supportive care trial for Nausea
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
Sites / Locations
- Englewood HealthRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
No Intervention
Arm Label
Acupuncture with Anti-Emetics
Aromatherapy with Anti-Emetics
Control Group
Arm Description
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT04116697
First Posted
October 3, 2019
Last Updated
July 25, 2022
Sponsor
Englewood Hospital and Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT04116697
Brief 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
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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 23, 2019 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Englewood Hospital and Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nausea, Vomiting, Anxiety
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Acupuncture with Anti-Emetics
Arm Type
Experimental
Arm Title
Aromatherapy with Anti-Emetics
Arm Type
Experimental
Arm Title
Control Group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Acupuncture
Intervention Description
Acupuncture is a form of alternative medicine in which thin needles are inserted into the body.
Intervention Type
Other
Intervention Name(s)
Aromatherapy
Intervention Description
Aromatherapy is a form of alternative medicine in which you will inhale aromatic plant extracts and essential oils.
Primary Outcome Measure Information:
Title
Improvement in Nausea
Description
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.
Time Frame
45 days
Title
improvement in anxiety
Description
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.
Time Frame
45 days
Title
improvement in vomiting
Description
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.
Time Frame
45 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jamie Ketas
Phone
201-894-3418
Email
Jamie.Ketas@EHMCHealth.org
Facility Information:
Facility Name
Englewood Health
City
Englewood
State/Province
New Jersey
ZIP/Postal Code
07631
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jamie Ketas
Phone
201-894-3418
Email
Jamie.Ketas@EHMCHealth.org
12. IPD Sharing Statement
Learn more about this trial
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
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