Chemotherapy-induced Nausea and Vomiting
Conditions
Brief summary
The purpose of this study is to evaluate the use of aromatherapy to reduce nausea, vomiting, and the use of anti-emetic in cancer survivors undergoing moderate to highly emetogenic chemotherapy regimens.
Interventions
DRUGStandard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV)
Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.
DRUGAromatherapy Care
An aromatherapy inhaler provided for use as needed after chemotherapy regimen given for up to 12 weeks. One normal inhale is equal to one dose of aromatherapy. Participants can use the aromatherapy as often as needed.
Sponsors
University of Miami
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. 18 years of age or older 2. Able to read and speak English or Spanish 3. Able to and willing to give informed consent 4. Currently undergoing moderate and high emetogenic chemotherapy (adjuvant or neoadjuvant) 5. Receiving three or more remaining cycles of chemotherapy 6. Symptoms of nausea or vomiting after the first chemotherapy infusion
Exclusion criteria
1. Unable or unwilling to give informed consent 2. Sensitivity to essential oils\* 3. Olfactory disorders 4. Receiving chemotherapy for the first time 5. Undergoing low emetogenic chemotherapy regimens 6. Patients with hormone-sensitive cancers 7. Timely request of treating provider
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute and Delayed Chemotherapy-Induced Nausea. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | 24 hours and 2 to 4 days post chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks. | Assessed by the mean/average score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT). The scores were averaged across three visits to generate the reported values. The Antiemesis (MAT) tool is a user-friendly and reliable tool designed to measure acute and delayed Chemotherapy-Induced Nausea & Vomiting across patients' entire chemotherapy regimens. The acute phase is during the first 24 hours after receiving chemotherapy. The delayed phase is 2 to 4 days after chemotherapy treatment. The MAT tool assessment has a total score of 0-10 (how much nausea did you have over this period), with the higher scores indicating a higher level of nausea. The completed self-reported instruments were collected on study visits 1, 2, and 3, following their scheduled outpatient chemotherapy sessions. The participants' study visits 1, 2, and 3 schedules are based on their prescribed chemotherapy regimen duration, ranging from every two to four weeks for up to 12 weeks. |
| Acute and Delayed Chemotherapy-Induced Vomiting. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | 24 hours and 2 to 4 days post chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks. | Assessed by the mean/average score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT). The MAT measures acute and delayed Chemotherapy-Induced vomiting (CINV) across patients' chemotherapy regimens using the question(s), In the 24 hours since chemotherapy, did you have any vomiting? and Did you vomit 24 hours or more after chemotherapy? respectively. Response options for both questions are a dichotomized Yes/No option. The percentage of participants who responded in the affirmative Yes were averaged with a score (ranging from 0-100%). The scores were averaged across three visits to generate the reported values. The completed self-reported instruments were collected on study visits 1, 2, and 3, following their scheduled outpatient chemotherapy sessions. The participants' study visits 1, 2, and 3 schedules are based on their prescribed chemotherapy regimen duration, ranging from every two to four weeks for up to 12 weeks. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Frequency of Antiemetic Medication Usage. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | Daily post-chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks. | Assessed by the average number of times antiemetic medications were used. The scores were averaged across three visits to generate the reported values. The completed self-reported instruments are collected on study visits 1, 2, and 3, following their scheduled outpatient chemotherapy sessions. The participants' study visits 1, 2, and 3 schedules are based on their prescribed chemotherapy regimen duration, ranging from every two to four weeks for up to 12 weeks. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Standard of Care With No Study Intervention Participants will receive standard medical care, consisting of antiemetic medicine at the first sign of Chemotherapy-Induced Nausea and Vomiting (CINV) on a schedule as prescribed by the healthcare provider.
Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV): Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks. | 48 |
| Standard of Care With Study Intervention Participants will receive an aromatherapy inhaler for complementary in addition to their standard of care antiemetic medication for Chemotherapy-Induced Nausea and Vomiting (CINV).
Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV): Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks.
Aromatherapy Care: An aromatherapy inhaler provided for use as needed after chemotherapy regimen given for up to 12 weeks. One normal inhale is equal to one dose of aromatherapy. Participants can use the aromatherapy as often as needed. | 52 |
| Total | 100 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Death | 1 | 1 |
| Overall Study | Lost to Follow-up | 3 | 1 |
| Overall Study | Withdrawal by Subject | 1 | 7 |
Baseline characteristics
| Characteristic | Standard of Care With No Study Intervention | Standard of Care With Study Intervention | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 8 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 39 Participants | 44 Participants | 83 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 45 Participants | 44 Participants | 89 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 3 Participants | 7 Participants | 10 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 2 Participants | 2 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 2 Participants |
| Race (NIH/OMB) White | 47 Participants | 47 Participants | 94 Participants |
| Sex: Female, Male Female | 25 Participants | 35 Participants | 60 Participants |
| Sex: Female, Male Male | 23 Participants | 17 Participants | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 1 / 48 | 1 / 52 |
| other Total, other adverse events | 0 / 48 | 0 / 52 |
| serious Total, serious adverse events | 0 / 48 | 0 / 52 |
Outcome results
Primary
Acute and Delayed Chemotherapy-Induced Nausea. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.
Assessed by the mean/average score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT). The scores were averaged across three visits to generate the reported values. The Antiemesis (MAT) tool is a user-friendly and reliable tool designed to measure acute and delayed Chemotherapy-Induced Nausea & Vomiting across patients' entire chemotherapy regimens. The acute phase is during the first 24 hours after receiving chemotherapy. The delayed phase is 2 to 4 days after chemotherapy treatment. The MAT tool assessment has a total score of 0-10 (how much nausea did you have over this period), with the higher scores indicating a higher level of nausea. The completed self-reported instruments were collected on study visits 1, 2, and 3, following their scheduled outpatient chemotherapy sessions. The participants' study visits 1, 2, and 3 schedules are based on their prescribed chemotherapy regimen duration, ranging from every two to four weeks for up to 12 weeks.
Time frame: 24 hours and 2 to 4 days post chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care With No Study Intervention | Acute and Delayed Chemotherapy-Induced Nausea. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | Acute Nausea (24 hours after chemotherapy begins) - MAT Question # 4 | 5.35 score on a scale | Standard Deviation 0.3 |
| Standard of Care With No Study Intervention | Acute and Delayed Chemotherapy-Induced Nausea. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | Delayed Nausea (4 days after chemotherapy begins)- MAT Question # 8 | 5.20 score on a scale | Standard Deviation 0.3 |
| Standard of Care With Study Intervention | Acute and Delayed Chemotherapy-Induced Nausea. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | Acute Nausea (24 hours after chemotherapy begins) - MAT Question # 4 | 4.57 score on a scale | Standard Deviation 0.34 |
| Standard of Care With Study Intervention | Acute and Delayed Chemotherapy-Induced Nausea. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | Delayed Nausea (4 days after chemotherapy begins)- MAT Question # 8 | 4.55 score on a scale | Standard Deviation 0.08 |
Primary
Acute and Delayed Chemotherapy-Induced Vomiting. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.
Assessed by the mean/average score of the Multi Association of Supportive Care in Cancer (MASCC) Antiemesis tool (MAT). The MAT measures acute and delayed Chemotherapy-Induced vomiting (CINV) across patients' chemotherapy regimens using the question(s), In the 24 hours since chemotherapy, did you have any vomiting? and Did you vomit 24 hours or more after chemotherapy? respectively. Response options for both questions are a dichotomized Yes/No option. The percentage of participants who responded in the affirmative Yes were averaged with a score (ranging from 0-100%). The scores were averaged across three visits to generate the reported values. The completed self-reported instruments were collected on study visits 1, 2, and 3, following their scheduled outpatient chemotherapy sessions. The participants' study visits 1, 2, and 3 schedules are based on their prescribed chemotherapy regimen duration, ranging from every two to four weeks for up to 12 weeks.
Time frame: 24 hours and 2 to 4 days post chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Standard of Care With No Study Intervention | Acute and Delayed Chemotherapy-Induced Vomiting. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | Acute Vomiting-MAT | 11.1 percentage of participants | Standard Deviation 2.43 |
| Standard of Care With No Study Intervention | Acute and Delayed Chemotherapy-Induced Vomiting. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | Delayed Vomiting-MAT | 11.83 percentage of participants | Standard Deviation 4.79 |
| Standard of Care With Study Intervention | Acute and Delayed Chemotherapy-Induced Vomiting. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | Acute Vomiting-MAT | 7.77 percentage of participants | Standard Deviation 3.95 |
| Standard of Care With Study Intervention | Acute and Delayed Chemotherapy-Induced Vomiting. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | Delayed Vomiting-MAT | 5.95 percentage of participants | Standard Deviation 0 |
Secondary
Change in Frequency of Antiemetic Medication Usage. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3.
Assessed by the average number of times antiemetic medications were used. The scores were averaged across three visits to generate the reported values. The completed self-reported instruments are collected on study visits 1, 2, and 3, following their scheduled outpatient chemotherapy sessions. The participants' study visits 1, 2, and 3 schedules are based on their prescribed chemotherapy regimen duration, ranging from every two to four weeks for up to 12 weeks.
Time frame: Daily post-chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Standard of Care With No Study Intervention | Change in Frequency of Antiemetic Medication Usage. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | 9.89 average of medication use | Standard Deviation 1.41 |
| Standard of Care With Study Intervention | Change in Frequency of Antiemetic Medication Usage. The Self-reported Instruments Are Documented After the Chemotherapy Sessions and Collected on Study Visits 1, 2, and 3. | 3.06 average of medication use | Standard Deviation 0.35 |