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NCT Number: NCT04116697

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 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.

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Key information

Conditions

Nausea Anxiety Anxiety Disorders Mental Disorders Pathological Conditions, Signs and Symptoms Signs and Symptoms Signs and Symptoms, Digestive Vomiting

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Englewood Health

Englewood, New Jersey, 07631, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acupuncture

Other

Acupuncture is a form of alternative medicine in which thin needles are inserted into the body.

Aromatherapy

Other

Aromatherapy is a form of alternative medicine in which you will inhale aromatic plant extracts and essential oils.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Englewood Hospital and Medical Center

Other

Registry information

Important dates

Study start
2019
Primary completion
2024
Study completion
2024
First posted
Oct 7, 2019
Registry last updated
Apr 13, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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