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Trial record 1 of 1 for:    04116697
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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04116697
Recruitment Status : Not yet recruiting
First Posted : October 7, 2019
Last Update Posted : October 7, 2019
Sponsor:
Information provided by (Responsible Party):
Englewood Hospital and Medical Center

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

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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
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine


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



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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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

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

Sponsors and Collaborators
Englewood Hospital and Medical Center

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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: October 7, 2019
Last Verified: October 2019

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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
Signs and Symptoms
Doxorubicin
Liposomal doxorubicin
Cyclophosphamide
Antiemetics
Antibiotics, Antineoplastic
Antineoplastic Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Myeloablative Agonists
Autonomic Agents
Peripheral Nervous System Agents
Gastrointestinal Agents