Trial Outcomes & Findings for Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV) (NCT NCT05319860)
NCT ID: NCT05319860
Last Updated: 2025-04-17
Results Overview
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.
COMPLETED
PHASE2
100 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.
2025-04-17
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
48
|
52
|
|
Overall Study
COMPLETED
|
43
|
43
|
|
Overall Study
NOT COMPLETED
|
5
|
9
|
Reasons for withdrawal
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
Death
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
7
|
Baseline Characteristics
Aromatherapy for Chemotherapy-induced Nausea and Vomiting (CINV)
Baseline characteristics by cohort
| Measure |
Standard of Care With No Study Intervention
n=48 Participants
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.
|
Standard of Care With Study Intervention
n=52 Participants
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.
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
39 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
83 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
35 Participants
n=7 Participants
|
60 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=5 Participants
|
17 Participants
n=7 Participants
|
40 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
45 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
89 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
47 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care With No Study Intervention
n=48 Participants
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.
|
Standard of Care With Study Intervention
n=51 Participants
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.
|
|---|---|---|
|
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 0.30
|
4.57 score on a scale
Standard Deviation 0.34
|
|
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 0.30
|
4.55 score on a scale
Standard Deviation 0.08
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care With No Study Intervention
n=48 Participants
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.
|
Standard of Care With Study Intervention
n=51 Participants
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.
|
|---|---|---|
|
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
|
7.77 percentage of participants
Standard Deviation 3.95
|
|
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
|
5.95 percentage of participants
Standard Deviation 0
|
SECONDARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Standard of Care With No Study Intervention
n=48 Participants
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.
|
Standard of Care With Study Intervention
n=51 Participants
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.
|
|---|---|---|
|
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
|
3.06 average of medication use
Standard Deviation 0.35
|
Adverse Events
Standard of Care With No Study Intervention
Standard of Care With Study Intervention
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place