An official website of the United States government
Aromatherapy Essential Oils to Manage Anxiety and Nausea in Cancer Patients Receiving Infusion in the Ambulatory Setting
Trial Status: active
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.
Inclusion Criteria
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
Exclusion Criteria
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)
I. To determine the feasibility of utilizing aromatherapy essential oils during outpatient infusions.
II. To assess satisfaction of patients receiving aromatherapy essential oils during outpatient infusions.
SECONDARY OBJECTIVES:
I. To observe whether aromatherapy essential oils (compared to placebo aromatherapy) influence an increase or decrease in nausea in patients undergoing moderate-risk and a high-risk emetogenic chemotherapy regimen.
II. To observe whether aromatherapy essential oils (compared to placebo aromatherapy) influence an increase or decrease in anxiety in patients receiving infusions in the outpatient setting.
OUTLINE: Patients are randomized to 1 of 4 arms.
ARM I: Patients inhale peppermint essential oil via the personal inhalation device (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.
ARM II: 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.
ARM III: 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.
ARM IV: 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.
After completion of study intervention, patients are followed up at day 25.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationCity of Hope Comprehensive Cancer Center
