Aromatherapy Essential Oils to Manage Anxiety and Nausea in Cancer Patients Receiving Infusion in the Ambulatory Setting
Status
Conditions
Treatments
Study type
Funder types
Identifiers
Details and patient eligibility
About
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.
Full description
PRIMARY OBJECTIVES:
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.
Enrollment
Sex
Ages
Volunteers
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)
- Self-reported abnormal smelling abilities (for ex: ongoing sinus infections, long covid, etc.)
- Aromatherapy use in the last 30 days
Trial design
Primary purpose
Allocation
Interventional model
Masking
60 participants in 4 patient groups, including a placebo group
Trial contacts and locations
Loading...
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal