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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-04956 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 24459 | Other Identifier | City of Hope Medical Center | |
| P30CA033572 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| 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. |
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| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatherapy and Essential Oils | Procedure | Inhale peppermint oil |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard T Lee | City of Hope Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| City of Hope Medical Center | Recruiting | Duarte | California | 91010 | United States |
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| Aromatherapy and Essential Oils | Procedure | Inhale lavender oil |
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| Aromatherapy and Essential Oils | Procedure | Inhale ginger oil |
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| Aromatherapy and Essential Oils | Procedure | Inhale placebo jojoba oil |
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| Questionnaire Administration | Other | Ancillary studies |
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| At day 5 - up to 30 days post intervention |
| 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. | At day 5 - up to 30 days post intervention |
| 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). | At day 5 - up to 30 days post intervention |
| City of Hope at Irvine Lennar | Recruiting | Irvine | California | 92618 | United States |
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| ID | Term |
|---|---|
| D019341 | Aromatherapy |
| ID | Term |
|---|---|
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
| D008517 | Phytotherapy |
| D026421 | Sensory Art Therapies |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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