A Phase 2 interventional study of Essential oils and Placebo in Anxiety and Chemotherapy-induced Nausea and Vomiting, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2024-05-16.
Sponsored by Indiana University · Phase 2, Interventional, and Supportive care
The purpose of this study is to evaluate the effect of inhaled aromatherapy on symptoms of nausea/vomiting and anxiety in patients who have received a stem cell transplant. Aromatherapy involves essential oils from aromatic plants that can be absorbed into the body in different ways. Our study will be using inhaled aromatherapy, which has been found helpful for symptoms such as nausea/vomiting and anxiety.
The purpose of this study is to evaluate the efficacy of aromatherapy on symptoms of chemotherapy-induced nausea, vomiting, and retching (CINVR) and anxiety for patients hospitalized for hematopoietic stem cell transplant. The primary aim will be to evaluate the effect of inhaled aromatherapy on CINVR and anxiety symptoms compared to control for 48 hours. Secondary aims include (1) Evaluating patient satisfaction with aromatherapy at completion of study; (2) Evaluating the antiemetic administration between intervention and control groups during the 48-hour intervention time span; (3) Evaluating the number and incidence of unit falls pre and post intervention.
This study will be a randomized controlled trial. Prior to randomization, participants will be asked which symptom, nausea/vomiting or anxiety, is most burdensome for them. Participants will be stratified based on their identified symptom of burden (nausea/vomiting or anxiety) and will then be randomized to either the intervention or control group, with a target of 50 participants in the nausea/vomiting symptom group (25 intervention and 25 control) and 50 participants in the anxiety symptom group (25 intervention and 25 control). Intervention and control groups will receive Wyndmere Naturals, Inc. aromatherapy patches and a symptom diary. Participants in the intervention group indicating that nausea/vomiting is the primary symptom of concern will receive peppermint inhaled aromatherapy patches (or mandarin if peppermint intolerance indicted). Participants in the intervention group indicating that anxiety is the primary symptoms of concern with receive lavender inhaled aromatherapy patches. The control group will receive non-scented aromatherapy patches (i.e., blank hydrogel adhesive patches without essential oil infusion), so it will not be feasible to blind participants to group assignment. The control group will have the same interactions with the study team as the intervention group and will complete patch changes and a symptom diary to serve as an attention control.
5,063 studies on the registry are indexed under Anxiety Disorders; 1,408 are open to participants now.
This study's enrollment of 92 is above the median of 80 across 4,339 interventional studies indexed under Anxiety Disorders.
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Of its 148 completed or terminated interventional studies of FDA-regulated products, 117 (79%) have results posted.
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Exclusion Criteria:
Patients indicating that nausea/vomiting is their primary symptom of concern and are randomized to receive intervention will be allocated to the intervention - nausea/vomiting arm. This arm will receive peppermint inhaled aromatherapy patches (or mandarin as an alternative if they have a peppermint sensitivity).
Drug: Essential oils
Patients indicating that anxiety is their primary symptom of concern and are randomized to receive intervention will be allocated to the intervention - anxiety arm. This arm will receive lavender inhaled aromatherapy patches.
Drug: Essential oils
Patients indicating that nausea/vomiting is their primary symptom of concern and are randomized to receive control will be allocated to the control - nausea/vomiting arm. This arm will receive blank (no essential oil infusion) aromatherapy patches.
Drug: Placebo
Patients indicating that anxiety is their primary symptom of concern and are randomized to receive control will be allocated to the control - anxiety arm. This arm will receive blank (no essential oil infusion) aromatherapy patches.
Drug: Placebo
Participants will receive Wyndmere Naturals, Inc. aromatherapy patches. The hydrogel adhesive patches are infused with essential oil for inhaled aromatherapy treatment. The aromatherapy patches provide an occlusive barrier that is hypoallergenic, allowing essential oils to be inhaled without coming in direct contact with the skin. Participants indicating nausea/vomiting is their symptom of concern will receive peppermint aromatherapy patches (or mandarin if peppermint sensitivity). Participants indicating anxiety is their symptom of concern will receive lavender aromatherapy patches.
Patients assigned to either control group (nausea/vomiting or anxiety) will receive Wyndmere Naturals non-scented patches (i.e., blank hydrogel adhesive patches without essential oil infusion).
Chemotherapy-induced Nausea, Vomiting, and Retching (CINVR) Symptoms at Baseline, 25 Hours, and 48 Hours
CINVR involves three gastrointestinal symptoms (nausea, vomiting, retching) influenced by administration of chemotherapy. Nausea is expressed as an unpleasant feeling in the throat/epigastrium that can result in expulsion of stomach content, known as vomiting. Retching is the effort to expel stomach contents without success. The Rhodes Index of Nausea, Vomiting and Retching (INVR) was used to measure CINVR and includes 8 Likert-type items on a 5-point scale. Items are scored from 0 (least amount of distress) to 4 (the most distress) and added after reverse coding items 1,3,6, and 7 to calculate an overall INVR score. The overall score ranges from 0 to 32, with higher scores indicating higher symptom burden. Subscales for symptom experience, occurrence, and distress for each symptom (nausea, vomiting, retching) are calculated by adding corresponding scale items for each subscale. The ranges for each subscale were as follows: nausea experience (0-12), vomiting experience (0-12),
Time frame: baseline (0 hours) and post-intervention (24, 48 hours)
Anxiety Symptoms at Baseline 24 Hours, and 48 Hours
Anxiety is defined as excessive or persistent worry about aspects of life. Anxiety was measured using a shortened version of Spielberger's State Anxiety Inventory (SAI). The original SAI contains 20 items to measure state anxiety and items are scored using a 4-point Likert-type scale (almost never-almost always). The shortened SAI retains 6 items (from the original 20) and has evidence supporting good internal reliability consistency and strong construct validity. Items are scored from 1 (not at all) to 4 (very much so) and added after reverse coding anxiety absent items, with higher total scores indicating higher state anxiety. The shortened SAI total score ranges from a total score of 6-24.
Time frame: baseline (0 hours) and post-intervention (24, 48 hours)
Patient Satisfaction at 48 Hours
An investigator-developed questionnaire was administered at the 48-hour study completion to evaluate patient satisfaction. Participants rated their satisfaction with the intervention on a 1-10 rating scale, with 10 being extremely satisfied (e.g., higher score means higher satisfaction).
Time frame: post-intervention (48 hours)
Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe
Medications administered for nausea/vomiting indication (scopolamine, lorazepam, promethazine, prochlorperazine, olanzapine, dexamethasone, Marinol, ondansetron). Medications administered for nausea/vomiting symptom indication were extracted from the electronic medical record for participants in the nausea/vomiting symptom group.
Time frame: 48 hour intervention timeframe
Inpatient Fall Events at Baseline and During Intervention
Fall numbers using total number of falls reported to the National Database of Nurse Quality Indicators. Data were extracted from the bone marrow transplant and hematology/oncology units for baseline (December 2020-March 2022) and intervention (March 2022-June 2023) timeframes.
Time frame: baseline (December 2020-February 2022) and during intervention (March 2022-June 2023)
| Milestone | Intervention - Nausea/Vomiting | Intervention - Anxiety | Control - Nausea/Vomiting | Control - Anxiety |
|---|---|---|---|---|
| Started | 24 | 21 | 26 | 21 |
| Completed | 19 | 15 | 20 | 17 |
| Not completed | 5 | 6 | 6 | 4 |
CINVR involves three gastrointestinal symptoms (nausea, vomiting, retching) influenced by administration of chemotherapy. Nausea is expressed as an unpleasant feeling in the throat/epigastrium that can result in expulsion of stomach content, known as vomiting. Retching is the effort to expel stomach contents without success. The Rhodes Index of Nausea, Vomiting and Retching (INVR) was used to measure CINVR and includes 8 Likert-type items on a 5-point scale. Items are scored from 0 (least amount of distress) to 4 (the most distress) and added after reverse coding items 1,3,6, and 7 to calculate an overall INVR score. The overall score ranges from 0 to 32, with higher scores indicating higher symptom burden. Subscales for symptom experience, occurrence, and distress for each symptom (nausea, vomiting, retching) are calculated by adding corresponding scale items for each subscale. The ranges for each subscale were as follows: nausea experience (0-12), vomiting experience (0-12),
| score on a scale | Intervention - Nausea/Vomiting | Control - Nausea/Vomiting |
|---|---|---|
| Baseline | 9.6 ± 4.6 | 8.5 ± 4.4 |
| 24 hours | 5.2 ± 3.1 | 4.9 ± 3.5 |
| 48 hours | 3.9 ± 3.5 | 4.4 ± 4.4 |
Anxiety is defined as excessive or persistent worry about aspects of life. Anxiety was measured using a shortened version of Spielberger's State Anxiety Inventory (SAI). The original SAI contains 20 items to measure state anxiety and items are scored using a 4-point Likert-type scale (almost never-almost always). The shortened SAI retains 6 items (from the original 20) and has evidence supporting good internal reliability consistency and strong construct validity. Items are scored from 1 (not at all) to 4 (very much so) and added after reverse coding anxiety absent items, with higher total scores indicating higher state anxiety. The shortened SAI total score ranges from a total score of 6-24.
| score on a scale | Intervention - Anxiety | Control - Anxiety |
|---|---|---|
| Baseline | 14.4 ± 3.7 | 15.4 ± 4.1 |
| 24 hours | 10.9 ± 3.3 | 13.3 ± 3.5 |
| 48 hours | 10.5 ± 3.4 | 12.9 ± 4.1 |
An investigator-developed questionnaire was administered at the 48-hour study completion to evaluate patient satisfaction. Participants rated their satisfaction with the intervention on a 1-10 rating scale, with 10 being extremely satisfied (e.g., higher score means higher satisfaction).
| Participants | Intervention - Nausea/Vomiting | Intervention - Anxiety | Control - Nausea/Vomiting | Control - Anxiety |
|---|---|---|---|---|
| Rating = 1 | 0 | 0 | 0 | 0 |
| Rating = 2 | 0 | 0 | 1 | 0 |
| Rating = 3 | 0 | 0 | 2 | 0 |
| Rating = 4 | 0 | 0 | 1 | 0 |
| Rating = 5 | 0 | 2 | 2 | 1 |
| Rating = 6 | 1 | 1 | 3 | 5 |
| Rating = 7 | 2 | 0 | 3 | 0 |
| Rating = 8 | 5 | 3 | 5 | 2 |
| Rating = 9 | 8 | 2 | 1 | 4 |
| Rating =10 | 5 | 7 | 2 | 6 |
Medications administered for nausea/vomiting indication (scopolamine, lorazepam, promethazine, prochlorperazine, olanzapine, dexamethasone, Marinol, ondansetron). Medications administered for nausea/vomiting symptom indication were extracted from the electronic medical record for participants in the nausea/vomiting symptom group.
| Medications Administered | Intervention - Nausea/Vomiting | Control - Nausea/Vomiting |
|---|---|---|
| Medications Administered for Nausea/Vomiting Indication for 48 Hour Study Timeframe | 10.0 ± 5.0 | 7.1 ± 5.3 |
Fall numbers using total number of falls reported to the National Database of Nurse Quality Indicators. Data were extracted from the bone marrow transplant and hematology/oncology units for baseline (December 2020-March 2022) and intervention (March 2022-June 2023) timeframes.
| Fall Events | Participating Units |
|---|---|
| Baseline | 32 |
| Post | 31 |
Collected over Events monitored from enrollment to 72 hours post enrollment for intervention group participants only (control did not receive essential oils).. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention - Nausea/Vomiting | 0/24 (0%) | 0/24 (0%) | 9/24 (37.5%) |
| Intervention - Anxiety | 0/21 (0%) | 1/21 (4.8%) | 12/21 (57.1%) |
| Event | Intervention - Nausea/Vomiting | Intervention - Anxiety |
|---|---|---|
| SepsisInfections and infestations | 0/24 | 1/21 |
| Respiratory failureRespiratory, thoracic and mediastinal disorders | 0/24 | 1/21 |
| Event | Intervention - Nausea/Vomiting | Intervention - Anxiety |
|---|---|---|
| FatigueGeneral disorders | 3/24 | 6/21 |
| MucositisInfections and infestations | 6/24 | 3/21 |
| PancytopeniaImmune system disorders | 6/24 | 4/21 |
| DiarrheaGastrointestinal disorders | 5/24 | 4/21 |
| Neutropenic FeverImmune system disorders | 5/24 | 3/21 |
| NauseaGastrointestinal disorders | 4/24 | 1/21 |
| DysuriaRenal and urinary disorders | 0/24 | 3/21 |
| VomitingGastrointestinal disorders | 3/24 | 1/21 |
| OrthostasisGeneral disorders | 3/24 | 0/21 |
| EpistaxisRespiratory, thoracic and mediastinal disorders | 0/24 | 2/21 |
| Age, Continuous(Years) | Intervention - Nausea/Vomiting | Intervention - Anxiety | Control - Nausea/Vomiting | Control - Anxiety | Total |
|---|---|---|---|---|---|
| Mean | 55 (22 to 72) | 51 (24 to 79) | 52 (22 to 78) | 51 (21 to 70) | 52 (21 to 79) |
| Sex: Female, Male(Participants) | Intervention - Nausea/Vomiting | Intervention - Anxiety | Control - Nausea/Vomiting | Control - Anxiety | Total |
|---|---|---|---|---|---|
| Female | 17 | 16 | 10 | 12 | 55 |
| Male | 7 | 5 | 16 | 9 | 37 |
| Race/Ethnicity, Customized(Participants) | Intervention - Nausea/Vomiting | Intervention - Anxiety | Control - Nausea/Vomiting | Control - Anxiety | Total |
|---|---|---|---|---|---|
| Native American or American Indian | 0 | 0 | 0 | 0 | 0 |
| Asian or Pacific Islander | 0 | 0 | 1 | 0 | 1 |
| Latino | 0 | 1 | 0 | 0 | 1 |
| Black or African American | 4 | 3 | 3 | 2 | 12 |
| White/Non-Hispanic | 20 | 17 | 22 | 19 | 78 |
| Other | 0 | 0 | 0 | 0 | 0 |
| Prefer Not to Say | 0 | 0 | 0 | 0 | 0 |
| Transplant Type(Participants) | Intervention - Nausea/Vomiting | Intervention - Anxiety | Control - Nausea/Vomiting | Control - Anxiety | Total |
|---|---|---|---|---|---|
| Allogenic | 1 | 3 | 5 | 7 | 16 |
| Autologous | 23 | 18 | 21 | 14 | 76 |
| Cancer Type(Participants) | Intervention - Nausea/Vomiting | Intervention - Anxiety | Control - Nausea/Vomiting | Control - Anxiety | Total |
|---|---|---|---|---|---|
| Leukemia | 1 | 3 | 4 | 4 | 12 |
| Dendritic Cell | 0 | 0 | 1 | 0 | 1 |
| Germ Cell Tumor | 3 | 2 | 4 | 1 | 10 |
| Hodgkin's Disease | 0 | 3 | 0 | 3 | 6 |
| Myelodysplastic Syndromes | 0 | 0 | 0 | 2 | 2 |
| Multiple Myeloma | 20 | 13 | 16 | 11 | 60 |
| Non-Hodgkin's Lymphoma | 0 | 0 | 1 | 0 | 1 |
| Chemotherapy Regimen(Participants) | Intervention - Nausea/Vomiting | Intervention - Anxiety | Control - Nausea/Vomiting | Control - Anxiety | Total |
|---|---|---|---|---|---|
| BEAM | 0 | 3 | 1 | 2 | 6 |
| Etoposide/Carboplatin | 3 | 2 | 4 | 1 | 10 |
| Fludarabine/Cytoxan/Total Body Irradiation | 0 | 0 | 1 | 0 | 1 |
| Fludarabine/Cytoxan | 0 | 0 | 1 | 3 | 4 |
| Melphalan | 20 | 13 | 16 | 11 | 60 |
| Thiotepa/Cytoxan | 1 | 3 | 2 | 4 | 10 |
| Triptycene/Cytoxan/Fludarabine | 0 | 0 | 1 | 0 | 1 |
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Plan to share: No
Ran from Mar 2022 to primary completion in Jun 2023, 15 months.
Results were first posted in May 2024, 10 months after primary completion.
Of 65 non-industry phase 2 interventional studies under Anxiety Disorders, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 53. This study's 15 months is below that.
Counting every sponsor, half of 81 studies reached it within 34 months; a quarter within 16 and three quarters within 53.
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This study is completed, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Oils, Volatile