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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard of Care With No Study Intervention | Active Comparator | 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. |
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| Standard of Care With Study Intervention | Experimental | Participants will receive an aromatherapy inhaler for complementary in addition to their standard of care antiemetic medication for Chemotherapy-Induced Nausea and Vomiting (CINV). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care Treatment for Chemotherapy Induced Nausea and Vomiting (CINV) | Drug | Standard of care for CINV includes anti-nausea medication as needed after chemotherapy regimen given for up to 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. |
| 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debbie Anglade, PhD | University of Miami | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Miami | Miami | Florida | 33136 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | score on a scale | 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. |
12 weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Debbie Anglade | University of Miami | 305-284-2388 | d.anglade@miami.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 13, 2023 | Jan 8, 2025 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D014839 | Vomiting |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Aromatherapy Care | Drug | 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. |
|
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| Daily post-chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks. |
| Withdrawal by Subject |
|
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
|
| ID | Title | Description |
|---|---|---|
| OG000 | 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. |
| OG001 | 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. |
|
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| 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. | Posted | Mean | Standard Deviation | average of medication use | Daily post-chemotherapy on study visits 1, 2, and 3 every two to four weeks for up to 12 weeks. |
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| 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. | Posted | Mean | Standard Deviation | percentage of participants | 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. |
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| 1 |
| 48 |
| 0 |
| 48 |
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| 48 |
| EG001 | 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. | 1 | 52 | 0 | 52 | 0 | 52 |
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