Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)

NCT05319860 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 20201412
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Chemotherapy-induced Nausea and Vomiting

Outcome Measures

Primary Outcomes (2)

• Acute and Delayed Chemotherapy-Induced Nausea. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.

  Assessed by the mean/average score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT). The scores were averaged across three visits to generate the reported values. The Antiemesis (MAT) tool is a user-friendly and reliable tool designed to measure acute and delayed Chemotherapy-Induced Nausea \& Vomiting across patients' entire chemotherapy regimens. The acute phase is during the first 24 hours after receiving chemotherapy. The delayed phase is 2 to 4 days after chemotherapy treatment. The MAT tool assessment has a total score of 0-10 (how much nausea did you have over this period), with the higher scores indicating a higher level of nausea. The completed self-reported instruments were collected on study visits 1, 2, and 3, following their scheduled outpatient chemotherapy sessions. The participants' study visits 1, 2, and 3 schedules are based on their prescribed chemotherapy regimen duration, ranging from every two to four weeks for up to 12 weeks.

  24 hours and 2 to 4 days post chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.

• Acute and Delayed Chemotherapy-Induced Vomiting. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.

  Assessed by the mean/average score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT). The MAT measures acute and delayed Chemotherapy-Induced vomiting (CINV) across patients' chemotherapy regimens using the question(s), "In the 24 hours since chemotherapy, did you have any vomiting?" and "Did you vomit 24 hours or more after chemotherapy?" respectively. Response options for both questions are a dichotomized Yes/No option. The percentage of participants who responded in the affirmative "Yes" were averaged with a score (ranging from 0-100%). The scores were averaged across three visits to generate the reported values. The completed self-reported instruments were collected on study visits 1, 2, and 3, following their scheduled outpatient chemotherapy sessions. The participants' study visits 1, 2, and 3 schedules are based on their prescribed chemotherapy regimen duration, ranging from every two to four weeks for up to 12 weeks.

  24 hours and 2 to 4 days post chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.

Secondary Outcomes (1)

• Change in Frequency of Antiemetic Medication Usage. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.

  Daily post-chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.

Study Arms (2)

Standard of Care With No Study Intervention

ACTIVE COMPARATOR

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.

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

Standard of Care With Study Intervention

EXPERIMENTAL

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

Drug: Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV); Drug: Aromatherapy Care

Interventions

Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV) 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 No Study Intervention; Standard of Care With Study Intervention

Aromatherapy Care 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.

Also known as: Soothing Scents QueaseEase aromatherapy inhalers

Standard of Care With Study Intervention

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Miami: lead

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

Location

MeSH Terms

Conditions

Vomiting

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Dr. Debbie Anglade
• Organization: University of Miami

d.anglade@miami.edu

305-284-2388

Study Officials

• Debbie Anglade, PhD

  University of Miami

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Clinical

Study Record Dates

• First Submitted: March 31, 2022
• First Posted: April 8, 2022
• Study Start: August 1, 2022
• Primary Completion: April 15, 2024
• Study Completion: April 15, 2024
• Last Updated: April 17, 2025
• Results First Posted: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)