Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)

NCT ID: NCT05319860

Last Updated: 2025-04-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2024-04-15

Brief Summary

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The purpose of this study is to evaluate the use of aromatherapy to reduce nausea, vomiting, and the use of anti-emetic in cancer survivors undergoing moderate to highly emetogenic chemotherapy regimens.

Detailed Description

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Conditions

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Chemotherapy-induced Nausea and Vomiting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Standard of Care With No Study Intervention

Participants will receive standard medical care, consisting of antiemetic medicine at the first sign of Chemotherapy-Induced Nausea and Vomiting (CINV) on a schedule as prescribed by the healthcare provider.

Group Type ACTIVE_COMPARATOR

Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)

Intervention Type DRUG

Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.

Standard of Care With Study Intervention

Participants will receive an aromatherapy inhaler for complementary in addition to their standard of care antiemetic medication for Chemotherapy-Induced Nausea and Vomiting (CINV).

Group Type EXPERIMENTAL

Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)

Intervention Type DRUG

Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.

Aromatherapy Care

Intervention Type DRUG

An aromatherapy inhaler provided for use as needed after chemotherapy regimen given for up to 12 weeks. One normal inhale is equal to one dose of aromatherapy. Participants can use the aromatherapy as often as needed.

Interventions

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Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)

Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.

Intervention Type DRUG

Aromatherapy Care

An aromatherapy inhaler provided for use as needed after chemotherapy regimen given for up to 12 weeks. One normal inhale is equal to one dose of aromatherapy. Participants can use the aromatherapy as often as needed.

Intervention Type DRUG

Other Intervention Names

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Soothing Scents QueaseEase aromatherapy inhalers

Eligibility Criteria

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Inclusion Criteria

1. 18 years of age or older
2. Able to read and speak English or Spanish
3. Able to and willing to give informed consent
4. Currently undergoing moderate and high emetogenic chemotherapy (adjuvant or neoadjuvant)
5. Receiving three or more remaining cycles of chemotherapy
6. Symptoms of nausea or vomiting after the first chemotherapy infusion

Exclusion Criteria

1. Unable or unwilling to give informed consent
2. Sensitivity to essential oils\*
3. Olfactory disorders
4. Receiving chemotherapy for the first time
5. Undergoing low emetogenic chemotherapy regimens
6. Patients with hormone-sensitive cancers
7. Timely request of treating provider
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Debbie Anglade, PhD, MSN, RN

Assistant Professor of Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Debbie Anglade, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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20201412

Identifier Type: -

Identifier Source: org_study_id

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