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

NCT04116697 | Completed

• 1 other identifier: E-19-773
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Nausea; Vomiting; Anxiety

Outcome Measures

Primary Outcomes (3)

• 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

• 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

• 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

Study Arms (3)

Acupuncture with Anti-Emetics

EXPERIMENTAL

Other: Acupuncture

Aromatherapy with Anti-Emetics

EXPERIMENTAL

Other: Aromatherapy

Control Group

NO INTERVENTION

Interventions

Acupuncture OTHER

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

Acupuncture with Anti-Emetics

Aromatherapy OTHER

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

Aromatherapy with Anti-Emetics

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Englewood Hospital and Medical Center: lead

Study Sites (1)

Englewood Health

Englewood, New Jersey, 07631, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting; Anxiety Disorders

Interventions

Acupuncture Therapy; Aromatherapy

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Intervention Hierarchy (Ancestors)

Complementary Therapies; Therapeutics; Mind-Body Therapies; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2019
• First Posted: October 7, 2019
• Study Start: October 23, 2019
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: April 13, 2025

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)