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

NCT ID: NCT04116697

Last Updated: 2025-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-10-23

Study Completion Date

2024-10-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Nausea Vomiting Anxiety

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Acupuncture with Anti-Emetics

Group Type EXPERIMENTAL

Acupuncture

Intervention Type OTHER

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

Aromatherapy with Anti-Emetics

Group Type EXPERIMENTAL

Aromatherapy

Intervention Type OTHER

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

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Acupuncture

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

Intervention Type OTHER

Aromatherapy

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Englewood Hospital and Medical Center

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Englewood Health

Englewood, New Jersey, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

E-19-773

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Ashwagandha for Cognitive Dysfunction
NCT04092647 UNKNOWN PHASE2