Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)

University of Miami

Status and phase: Completed; Phase 2

Conditions: Chemotherapy-induced Nausea and Vomiting

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05319860

20201412

Details and patient eligibility

About

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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Standard of Care With No Study Intervention

Active Comparator group

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.

Treatment:

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

Standard of Care With Study Intervention

Experimental group

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).

Treatment:

Drug: Aromatherapy Care

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