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Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)

Primary Purpose

Chemotherapy-induced Nausea and Vomiting

Status
Enrolling by invitation
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)
Aromatherapy Care
Sponsored by
University of Miami
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Chemotherapy-induced Nausea and Vomiting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Miami

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care With No Study Intervention

Standard of Care With Study Intervention

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in severity of Chemotherapy-Induced Nausea and Vomiting (CINV)
Assessed by the mean score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT), which measures acute and delayed CINV across patients' chemotherapy regimens. The MAT tool has a total score measured from zero to ten with the higher score indicating a higher level of nausea and vomiting.

Secondary Outcome Measures

Change in frequency of Antiemetic Medication
Assessed by the mean score of antiemetics diary, which measures the usage frequency (date and time)
Type of antiemetic medications
Participants will complete an Anti-Emetic Diary which will track their anti-emetic medications to combat nausea.

Full Information

First Posted
March 31, 2022
Last Updated
July 10, 2023
Sponsor
University of Miami
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1. Study Identification

Unique Protocol Identification Number
NCT05319860
Brief Title
Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)
Official Title
Effects of Aromatherapy on Chemotherapy-Induced Nausea and Vomiting: A Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
August 1, 2024 (Anticipated)
Study Completion Date
August 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chemotherapy-induced Nausea and Vomiting

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care With No Study Intervention
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Standard of Care With Study Intervention
Arm Type
Experimental
Arm Description
Participants will receive an aromatherapy inhaler for complementary in addition to their standard of care antiemetic medication for Chemotherapy-Induced Nausea and Vomiting (CINV).
Intervention Type
Drug
Intervention Name(s)
Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)
Intervention Description
Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.
Intervention Type
Drug
Intervention Name(s)
Aromatherapy Care
Other Intervention Name(s)
Soothing Scents QueaseEase aromatherapy inhalers
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in severity of Chemotherapy-Induced Nausea and Vomiting (CINV)
Description
Assessed by the mean score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT), which measures acute and delayed CINV across patients' chemotherapy regimens. The MAT tool has a total score measured from zero to ten with the higher score indicating a higher level of nausea and vomiting.
Time Frame
Baseline, up to 12 weeks
Secondary Outcome Measure Information:
Title
Change in frequency of Antiemetic Medication
Description
Assessed by the mean score of antiemetics diary, which measures the usage frequency (date and time)
Time Frame
Baseline, up to 12 weeks
Title
Type of antiemetic medications
Description
Participants will complete an Anti-Emetic Diary which will track their anti-emetic medications to combat nausea.
Time Frame
Up to 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years of age or older Able to read and speak English or Spanish Able to and willing to give informed consent Currently undergoing moderate and high emetogenic chemotherapy (adjuvant or neoadjuvant) Receiving three or more remaining cycles of chemotherapy Symptoms of nausea or vomiting after the first chemotherapy infusion Exclusion Criteria: Unable or unwilling to give informed consent Sensitivity to essential oils* Olfactory disorders Receiving chemotherapy for the first time Undergoing low emetogenic chemotherapy regimens Patients with hormone-sensitive cancers Timely request of treating provider
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debbie Anglade, PhD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)

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