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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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ClinicalTrials.gov Identifier: NCT04116697
Recruitment Status : Recruiting
First Posted : October 7, 2019
Last Update Posted : February 7, 2020
Sponsor:
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

Study Description
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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.

Condition or disease Intervention/treatment Phase
Nausea Vomiting Anxiety Other: Acupuncture Other: Aromatherapy Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : October 23, 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
No Intervention: Control Group


Outcome Measures
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Primary Outcome Measures :
  1. Improvement in Nausea [ Time Frame: 45 days ]
    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.

  2. improvement in anxiety [ Time Frame: 45 days ]
    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.

  3. improvement in vomiting [ Time Frame: 45 days ]
    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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04116697


Contacts
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Contact: Jamie Ketas 201-894-3418 Jamie.Ketas@EHMCHealth.org

Locations
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United States, New Jersey
Englewood Health Recruiting
Englewood, New Jersey, United States, 07631
Contact: Jamie Ketas    201-894-3418    Jamie.Ketas@EHMCHealth.org   
Sponsors and Collaborators
Englewood Hospital and Medical Center
More Information
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Responsible Party: Englewood Hospital and Medical Center
ClinicalTrials.gov Identifier: NCT04116697    
Other Study ID Numbers: E-19-773
First Posted: October 7, 2019    Key Record Dates
Last Update Posted: February 7, 2020
Last Verified: February 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nausea
Vomiting
Anxiety Disorders
Mental Disorders
Signs and Symptoms, Digestive