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.
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
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)
Parallel
Aromatherapy and Essential Oils
Procedure/SurgeryInhale peppermint oil
Aromatherapy and Essential Oils
Procedure/SurgeryInhale lavender oil
Aromatherapy and Essential Oils
Procedure/SurgeryInhale ginger oil
Aromatherapy and Essential Oils
Procedure/SurgeryInhale placebo jojoba oil
Questionnaire Administration
Other interventionAncillary studies
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.
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.
Nausea scores
Will be evaluated between groups using data from the post-infusion questionnaire which asks, "what was the highest level of nausea that you experienced during the infusion?" as well as nausea scores from the post-infusion visual analog scale (VAS) nausea, and the Rhodes Index of Nausea, Vomiting, and Retching (INVR). Will also assess longitudinal changes in nausea scores within and between groups (VAS).
Anxiety scores I
Will be evaluated between groups using data from the post-infusion questionnaire which asks, "what was the highest level of anxiety that you experienced during the infusion?" as well as anxiety scores from the pre- and post-infusion Edmonton Symptom Assessment Scale (ESAS), and post-infusion VAS anxiety.
Anxiety scores II - longitudinal changes
Will assess longitudinal changes in anxiety scores within and between groups (VAS, State-Trait Anxiety Inventory Long Form, Edmonton Symptom Assessment System).
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City of Hope Medical Center
Lead sponsor
National Cancer Institute (NCI)
Collaborator
