Aromatherapy Essential Oils to Manage Anxiety and Nausea in Cancer Patients Receiving Infusion in the Ambulatory Setting

NCT07126301 | Recruiting DMC

• 3 other identifiers: 24459NCI-2025-04956P30CA033572
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 2

Brief Summary

This clinical trial tests how well aromatherapy essential oils work to manage anxiety and nausea in cancer patients receiving infusions in the ambulatory setting. Current drugs that are given for nausea may cause constipation and fatigue. Therefore, there is interest in exploring complementary therapies, like aromatherapy, that do not carry the same side effects. Using aromatherapy essential oils such as ginger, peppermint, and lavender, may help reduce nausea and anxiety. Some studies have shown significant reductions in nausea and anxiety among cancer patients using these oils, while other studies have had mixed results. Ginger and peppermint oils, in particular, have been associated with helping reduce nausea during chemotherapy, while lavender has shown potential benefits for anxiety. Jojoba oil will be used as a placebo for this research study. Jojoba oil is extracted from the seeds of a jojoba plant, which is a green shrub that is found in the southwestern United States). Jojoba oil is an oil which has no color or smell. Aromatherapy essential oils used through a personal inhalation device during chemotherapy may better manage anxiety and nausea in cancer patients receiving infusions in the ambulatory setting.

Conditions

Hematopoietic and Lymphatic System Neoplasm; Malignant Solid Neoplasm

Outcome Measures

Primary Outcomes (2)

• Participation and completion rates

  Will consider the study feasible if \>= 70% of patients are able to complete the essential oil treatment (lavender, peppermint, ginger or placebo). Completion will be defined as receiving oil treatments and submitting 4 days of at-home questionnaires as described. Will consider the study feasible if \>= 50% of a patient's questionnaires are completed. Descriptive statistics will be provided to summarize all the above data.

  At day 5 - up to 30 days post intervention

• Satisfaction of patients treated with aromatherapy essential oils

  Will be evaluated via a post-infusion questionnaire, in order to fully understand their experience with the treatment. Will consider patients to be satisfied if \>= 50% of patients answer that they are "very satisfied" or "satisfied" on their post-infusion surveys. Will also evaluate whether the patients are interested in aromatherapy essential oils for future chemotherapy infusion appointments, and their experience in the clinical trial. Descriptive statistics will be provided.

  At day 5 - up to 30 days post intervention

Secondary Outcomes (3)

• Nausea scores

  At day 5 - up to 30 days post intervention

• Anxiety scores I

  At day 5 - up to 30 days post intervention

• Anxiety scores II - longitudinal changes

  At day 5 - up to 30 days post intervention

Study Arms (4)

Arm I (peppermint oil)

EXPERIMENTAL

Patients inhale peppermint essential oil via the PID once every hour starting on day 1 during their anti-cancer/chemotherapy infusions. Patients continue to inhale the peppermint essential oil via the PID at least three times a day for 4 days.

Procedure: Aromatherapy and Essential Oils; Other: Questionnaire Administration

Arm II (lavender oil)

EXPERIMENTAL

Patients inhale lavender essential oil via the PID once every hour starting on day 1 during their anti-cancer/chemotherapy infusions. Patients continue to inhale the lavender essential oil via the PID at least three times a day for 4 days.

Procedure: Aromatherapy and Essential Oils; Other: Questionnaire Administration

Arm III (ginger oil)

EXPERIMENTAL

Patients inhale ginger essential oil via the PID once every hour starting on day 1 during their anti-cancer/chemotherapy infusions. Patients continue to inhale the ginger essential oil via the PID at least three times a day for 4 days.

Procedure: Aromatherapy and Essential Oils; Other: Questionnaire Administration

Arm IV (placebo jojoba oil)

PLACEBO COMPARATOR

Patients inhale placebo jojoba essential oil via the PID once every hour starting on day 1 during their anti-cancer/chemotherapy infusions. Patients continue to inhale the placebo jojoba essential oil via the PID at least three times a day for 4 days.

Procedure: Aromatherapy and Essential Oils; Other: Questionnaire Administration

Interventions

Aromatherapy and Essential Oils PROCEDURE

Inhale peppermint oil

Also known as: Aromatherapy

Arm I (peppermint oil)

Questionnaire Administration OTHER

Ancillary studies

Arm I (peppermint oil); Arm II (lavender oil); Arm III (ginger oil); Arm IV (placebo jojoba oil)

Eligibility Criteria

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

You may qualify if:

• Patients must have the ability to understand and sign a written informed consent document, and be willing to follow protocol requirements
• Ability to read and understand English for patient reported outcomes
• Age \>= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
• Willingness to comply with all study interventions of essential oil aromatherapy
• Have been on a moderate- to high-risk emetogenic chemotherapy regimen as defined by the National Comprehensive Cancer Network (NCCN) for at least 1 cycle of therapy
• At least 2 remaining infusion appointments on a moderate- to high-risk emetogenic chemotherapy regimen as defined by the NCCN
• Have nausea defined as \> 3/10 with last chemotherapy infusion based on screening symptom questionnaire
• The study is open to all participants regardless of gender, race, or ethnicity

You may not qualify if:

• Self-reported aversion or sensitivity to lavender oil, peppermint oil, ginger oil, jojoba oil
• Uncontrolled respiratory conditions such as asthma and chronic obstructive pulmonary disease (COPD)
• Mental incapacitation (ex. stroke, brain metastasis etc.) that would cause inability to follow directions, in the opinion of the investigators
• Ongoing uncontrolled active psychiatric condition that would interfere in the conduct of the study (e.g., mood disorders, anxiety, psychosis disorders, or substance use)
• Self-reported abnormal smelling abilities (for ex: ongoing sinus infections, long covid, etc.)
• Aromatherapy use in the last 30 days

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

City of Hope Medical Center

Duarte, California, 91010, United States

RECRUITING

City of Hope at Irvine Lennar

Irvine, California, 92618, United States

RECRUITING

MeSH Terms

Interventions

Aromatherapy

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Richard T Lee

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2025
• First Posted: August 17, 2025
• Study Start: July 8, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: August 17, 2025

Record last verified: 2025-08

Locations

US (2)