NauseaCINVNCT04478630
The Effects of Inhaled Aromatherapy on Chemotherapy Induced Nausea (CINV) and Vomiting
A study testing Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract in people with Nausea and Vomiting, run by Milton S. Hershey Medical Center at 1 site in United States.
Trial summary
This study is a three group, randomized, double blind, placebo-controlled trial with two repeated measurements. The same measurements will be collected for each participant during two consecutive chemotherapy treatment cycles.Subjects will be provided with written instructions as an educational handout as well as… Read more about this study
- Who is it for?
- Ages 21 to 89 years
- What is being tested?
- Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Aug 2021to 18 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women included
- Ages between 21 years old and 89 years old
- Diagnosis of breast cancer - all histologies and stages
- Subjects must have reported some degree of nausea following chemotherapy
- Subjects must have at least two remaining cycles of chemotherapy to complete
- Subjects must be fluent in English or Spanish
- Subjects must be willing to complete questionnaire through follow-up phone calls
- Subjects must be able to use the pocket diffuser
Who cannot join
- Inability to sign the consent
- Pregnancy
- Cognitive impairment
- Current use of aromatherapy for symptom management or prevention
- Allergies to peppermint, ginger, or vanilla
- Concurrent radiation therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Penn State Cancer Institute
Hershey, Pennsylvania, 17033
About this study
Official title: The Effects of Inhaled Aromatherapy on Chemotherapy Induced Nausea and Vomiting (CINV) in Men and Women With Breast Cancer
This study is a three group, randomized, double blind, placebo-controlled trial with two repeated measurements. The same measurements will be collected for each participant during two consecutive chemotherapy treatment cycles.Subjects will be provided with written instructions as an educational handout as well as essential oil safety information. Subjects will be able to demonstrate an ability and accurate understanding of the proper use of the diffusers, using a demonstration diffuser, at the time of consent.
At the time the subject will provide written informed consent, they will be randomly assigned to one of the three groups with a pocket diffuser containing either ginger essential oil, peppermint essential oil, or vanilla extract )placebo- control). This is based on a pre-determined list of random assignments.
Read more
Each subject will be instructed to inhale from the pocket diffuser beginning on the day of their chemotherapy (Day 1) and continue using the inhaler for the next three consecutive days (Day 1-Day 4). The subjects will remove the cover of the pocket diffuser, place the pocket diffuser approximately an inch away from their nose and inhale three times with deep breathing (i.e., three sniffs). Subjects will take 3 sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening).
In addition to the Pre-treatment Assessment, occurring before each of the 2 cycles of chemotherapy, the subjects will be contacted to complete assessments at approximately 24 and 72 hours post-chemotherapy. A member of the study team will call the participant again at their preferred time of day to ask the survey questions.
The same procedures will be repeated during the participant's second cycle of chemotherapy, which is likely two or three weeks after the first one.
Read the detailed description
This study is a three group, randomized, double blind, placebo-controlled trial with two repeated measurements. The same measurements will be collected for each participant during two consecutive chemotherapy treatment cycles.
After subjects are identified to meet criteria and have reported some degree of nausea following chemotherapy, one of the Clinical Nurse Coordinators or Infusion Room Nurses on the research team will provide information regarding the study to the potential subject. If the potential subject is interested in participating in the study and physically demonstrates the ability to correctly use the pocket diffuser the consent will be gone over in detail with the potential subject and signed. Educational handouts outlining the instructions for use of the pocket diffuser as well as safety and contact information will be provided and explained to the subject at this time.
At the time the subject will provide written informed consent, they will be randomly assigned to one of the three groups (ginger essential oil, peppermint essential oil, or vanilla extract placebo- control) based on a pre-determined list of random assignments.
The diffusers will have been prepped with essential oils of either peppermint or ginger, which will each contain 14 drops of the designated essential oil. The nonessential oil diffusers (placebo) pure vanilla extract will also be prepared to each contain 14 drops each.
Prior to the start of the participant's chemotherapy infusion, all subjects will complete a pre-treatment survey to evaluate their baseline/anticipatory nausea. The pre-treatment survey will also include questions about the recent chemotherapy treatment experience related to appetite and the use of medication to prevent or lesson nausea.
Then, participants will be provided with their assigned pocket diffuser which has already been prepared with the correct substance (ginger essential oil, peppermint essential oil, or pure vanilla extract). Participants will be asked to remove the cover of the pocket diffuser, place the pocket diffuser about an inch under their nose, and inhale three times with deep breathing (i.e. three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take three sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening) starting at the time of the chemotherapy appointment through the final survey at 72 hours post-discharge. Subjects will be instructed on proper disposal and receive a new pocket-sized diffuser at the next treatment visit.
All participants will be encouraged to follow all standard procedures related to their treatment including the use of any prescribed anti-emetics. Aromatherapy is considered a complementary therapy and is not intended to replace any current treatments.
During the day after chemotherapy administration (approximately 24 hours post-discharge), a member of the study team will call the participant at their preferred time of day to conduct the first post-intervention survey. This survey will be identical to the baseline survey conducted on Day 1, but it will also include questions about the aromatherapy diffuser usage. By calling 24 hours after chemotherapy, the nausea reported by the participant can be classified as "acute nausea." Additionally, it will be documented as to if the subject required any antiemetics in addition to what was planned and ordered per the standard chemotherapy regimen.
Approximately 72 hours post-discharge, a member of the study team will call the participant again at their preferred time of day. The survey questions will be exactly the same as the first phone call. At this time point, it will be possible to evaluate "delayed nausea" related to chemotherapy. Again, it will be documented as to if the subject required any antiemetics in addition to what was planned and ordered per the standard chemotherapy regimen.
Participants will be reminded during the call that they will receive a phone call from the study team prior to their next chemotherapy appointment to remind them to return their used pocket diffuser for disposal. Returning the used diffuser from the previous cycle will be helpful to ensure that the subject will not confuse the diffuser from the 1st and 2nd cycles. Although both diffusers will contain the same thing (ginger essential oil, peppermint essential oil, or pure vanilla extract), the used diffuser would be less potent as it has been opened multiple times.
The exact same procedures will be repeated during the participant's next cycle of chemotherapy, which is likely two or three weeks after the first one.
- Being tested
- Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract
- Medical subject headings
- Nausea, Vomiting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla ExtractOther
Inhaled Aromatherapy via a pocket sized diffuser which contains one of the following:Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract (placebo-control).
| Study group | Role | What they receive |
|---|---|---|
| Peppermint Essential Oil | Active comparator | Usual care plus a personal pocket diffuser prepared with 14 drops of peppermint essential oil. Each subject will be instructed to inhale from the pocket diffuser beginning on the day of their chemotherapy (Day 1) and continue using the inhaler for the next three consecutive days (Day 1-Day 4).The subjects will remove the cover of the pocket diffuser, place the pocket diffuser approximately an inch away from their nose and inhale three times with deep breathing (i.e., three sniffs). Subjects will take 3 sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening).The subjects will complete a Pre-treatment Assessment form before cycle of chemotherapy (total of 2), as well as 24 and 72 hours after each cycle of chemotherapy. The exact same procedures will be repeated during the participant's next cycle of chemotherapy, which is likely two or three weeks after the first one. Receives: Other: Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract |
| Ginger Essential Oil | Active comparator | Usual care plus a personal pocket diffuser prepared with 14 drops of ginger essential oil. Each subject will be instructed to inhale from the pocket diffuser beginning on the day of their chemotherapy (Day 1) and continue using the inhaler for the next three consecutive days (Day 1-Day 4). The subjects will remove the cover of the pocket diffuser, place the pocket diffuser approximately an inch away from their nose and inhale three times with deep breathing (i.e., three sniffs). Subjects will take 3 sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening). The subjects will complete a Pre-treatment Assessment form before cycle of chemotherapy (total of 2), as well as 24 and 72 hours after each cycle of chemotherapy.The exact same procedures will be repeated during the participant's next cycle of chemotherapy, which is likely two or three weeks after the first one. Receives: Other: Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract |
| Pure Vanilla Extract (placebo-control) | Placebo comparator | Usual care plus a personal pocket diffuser prepared with 14 drops of pure vanilla extract (placebo). Each subject will be instructed to inhale from the pocket diffuser beginning on the day of their chemotherapy (Day 1) and continue using the inhaler for the next three consecutive days (Day 1-Day 4). The subjects will remove the cover of the pocket diffuser, place the pocket diffuser approximately an inch away from their nose and inhale three times with deep breathing (i.e., three sniffs). Subjects will take 3 sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening). The subjects will complete a Pre-treatment Assessment form before cycle of chemotherapy (total of 2), as well as 24 and 72 hours after each cycle of chemotherapy. The exact same procedures will be repeated during the participant's next cycle of chemotherapy, which is likely two or three weeks after the first one. Receives: Other: Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute Nausea Score
N\&V experienced during the first 24 hours after chemotherapy administration as measured by the Memorial Symptom Assessment Scale's nausea and vomiting dimension with values for symptoms, if experienced, on a 4-point scale; its frequency, if appropriate, on a 4-point scale; and its associated distress on a 5-point categorical scale. The higher the score determines a worse outcome in all areas.
Measured: 24 hours post-chemotherapy
Delayed Nausea Score
N\&V that occurs more than 24 hours after chemotherapy administration , as measured by the Memorial Symptom Assessment Scale's nausea and vomiting dimension, with values for symptoms, if experienced, on a 4-point scale; its frequency, if appropriate, on a 4-point scale; and its associated distress on a 5-point categorical scale. The higher the score determines a worse outcome in all areas.
Measured: 72 hours post-chemotherapy
Secondary outcomes (4)
Appetite For the 24 Hours Post-chemotherapy
Approximately 24 hours after chemotherapy administration, a member of the study team will call the participant at their preferred time of day to conduct a post-chemotherapy survey and include documentation of the questions regarding appetite: ability to eat as they normally would, less than they normally would eat, no appetite, or inability to eat most foods.
Measured: 24 hours post-chemotherapy
Appetite During the 72 Hours Post-chemotherapy
Approximately 72 hours after chemotherapy administration, a member of the study team will call the participant at their preferred time of day to conduct a post-chemotherapy survey and include documentation of the questions regarding appetite: ability to eat as they normally would, less than they normally would eat, no appetite, or inability to eat most foods.
Measured: 72 hours post-chemotherapy
Use of additional anti-emetic medications (in addition to the standard regimen's listed anti-emetics)
Approximately 24 hours after chemotherapy administration, a member of the study team will call the participant at their preferred time of day to conduct a post-chemotherapy survey and include documentation of the name and frequency of any anti-emetics used in addition to the standard regimen's anti-emetics.
Measured: 24 hours post-chemotherapy
Use of additional anti-emetic medications (in addition to the standard regimen's listed anti-emetics)
Approximately 72 hours after chemotherapy administration, a member of the study team will call the participant at their preferred time of day to conduct a post-chemotherapy survey and include documentation of the name and frequency of any anti-emetics used in addition to the standard regimen's anti-emetics.
Measured: 72 hours post-chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2020
- Study start30 Aug 2021
- Primary completion18 Jan 2023
- Study completion18 Feb 2023
Why it stopped: Investigator left institution
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NauseaStudies of the same condition, open and under way.
- More trials run by Milton S. Hershey Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study is a three group, randomized, double blind, placebo-controlled trial with two repeated measurements. The same measurements will be collected for each participant during two consecutive chemotherapy treatment cycles.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Milton S. Hershey Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Doctors Kienle Center for Humanistic Medicine/Penn State College of Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04478630
- Sponsor's protocol ID
- 19-104
- Acronym
- CINV
- Status last verified
- Sep 2023
- First submitted
- 7 Jul 2020
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The Clinical Study Report will be available to other researchers after the study and data are finalized.
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Inhaled Aromatherapy on Chemotherapy Induced Nausea and Vomiting (CINV) in Men and Women With Breast Cancer
- ClinicalTrials.gov ID
- NCT04478630
- Acronym / sponsor ID
- CINV / 19-104
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Investigator left institution
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Milton S. Hershey Medical CenterUniversity, hospital or other
- Collaborators
- Doctors Kienle Center for Humanistic Medicine/Penn State College of Medicine
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 18 Jan 2023 (actual)
- Study completion
- 18 Feb 2023 (actual)
- First posted
- 21 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a three group, randomized, double blind, placebo-controlled trial with two repeated measurements. The same measurements will be collected for each participant during two consecutive chemotherapy treatment cycles.Subjects will be provided with written instructions as an educational handout as well as essential oil safety information. Subjects will be able to demonstrate an ability and accurate understanding of the proper use of the diffusers, using a demonstration diffuser, at the time of consent.
At the time the subject will provide written informed consent, they will be randomly assigned to one of the three groups with a pocket diffuser containing either ginger essential oil, peppermint essential oil, or vanilla extract )placebo- control). This is based on a pre-determined list of random assignments.
Each subject will be instructed to inhale from the pocket diffuser beginning on the day of their chemotherapy (Day 1) and continue using the inhaler for the next three consecutive days (Day 1-Day 4). The subjects will remove the cover of the pocket diffuser, place the pocket diffuser approximately an inch away from their nose and inhale three times with deep breathing (i.e., three sniffs). Subjects will take 3 sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening).
In addition to the Pre-treatment Assessment, occurring before each of the 2 cycles of chemotherapy, the subjects will be contacted to complete assessments at approximately 24 and 72 hours post-chemotherapy. A member of the study team will call the participant again at their preferred time of day to ask the survey questions.
The same procedures will be repeated during the participant's second cycle of chemotherapy, which is likely two or three weeks after the first one.
Detailed description
This study is a three group, randomized, double blind, placebo-controlled trial with two repeated measurements. The same measurements will be collected for each participant during two consecutive chemotherapy treatment cycles.
After subjects are identified to meet criteria and have reported some degree of nausea following chemotherapy, one of the Clinical Nurse Coordinators or Infusion Room Nurses on the research team will provide information regarding the study to the potential subject. If the potential subject is interested in participating in the study and physically demonstrates the ability to correctly use the pocket diffuser the consent will be gone over in detail with the potential subject and signed. Educational handouts outlining the instructions for use of the pocket diffuser as well as safety and contact information will be provided and explained to the subject at this time.
At the time the subject will provide written informed consent, they will be randomly assigned to one of the three groups (ginger essential oil, peppermint essential oil, or vanilla extract placebo- control) based on a pre-determined list of random assignments.
The diffusers will have been prepped with essential oils of either peppermint or ginger, which will each contain 14 drops of the designated essential oil. The nonessential oil diffusers (placebo) pure vanilla extract will also be prepared to each contain 14 drops each.
Prior to the start of the participant's chemotherapy infusion, all subjects will complete a pre-treatment survey to evaluate their baseline/anticipatory nausea. The pre-treatment survey will also include questions about the recent chemotherapy treatment experience related to appetite and the use of medication to prevent or lesson nausea.
Then, participants will be provided with their assigned pocket diffuser which has already been prepared with the correct substance (ginger essential oil, peppermint essential oil, or pure vanilla extract). Participants will be asked to remove the cover of the pocket diffuser, place the pocket diffuser about an inch under their nose, and inhale three times with deep breathing (i.e. three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take three sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening) starting at the time of the chemotherapy appointment through the final survey at 72 hours post-discharge. Subjects will be instructed on proper disposal and receive a new pocket-sized diffuser at the next treatment visit.
All participants will be encouraged to follow all standard procedures related to their treatment including the use of any prescribed anti-emetics. Aromatherapy is considered a complementary therapy and is not intended to replace any current treatments.
During the day after chemotherapy administration (approximately 24 hours post-discharge), a member of the study team will call the participant at their preferred time of day to conduct the first post-intervention survey. This survey will be identical to the baseline survey conducted on Day 1, but it will also include questions about the aromatherapy diffuser usage. By calling 24 hours after chemotherapy, the nausea reported by the participant can be classified as "acute nausea." Additionally, it will be documented as to if the subject required any antiemetics in addition to what was planned and ordered per the standard chemotherapy regimen.
Approximately 72 hours post-discharge, a member of the study team will call the participant again at their preferred time of day. The survey questions will be exactly the same as the first phone call. At this time point, it will be possible to evaluate "delayed nausea" related to chemotherapy. Again, it will be documented as to if the subject required any antiemetics in addition to what was planned and ordered per the standard chemotherapy regimen.
Participants will be reminded during the call that they will receive a phone call from the study team prior to their next chemotherapy appointment to remind them to return their used pocket diffuser for disposal. Returning the used diffuser from the previous cycle will be helpful to ensure that the subject will not confuse the diffuser from the 1st and 2nd cycles. Although both diffusers will contain the same thing (ginger essential oil, peppermint essential oil, or pure vanilla extract), the used diffuser would be less potent as it has been opened multiple times.
The exact same procedures will be repeated during the participant's next cycle of chemotherapy, which is likely two or three weeks after the first one.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- This study is a three group, randomized, double blind, placebo-controlled trial with two repeated measurements. The same measurements will be collected for each participant during two consecutive chemotherapy treatment cycles.
| Arm | Type | Receives |
|---|---|---|
| Peppermint Essential Oil | Active comparator | Other: Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla ExtractUsual care plus a personal pocket diffuser prepared with 14 drops of peppermint essential oil. Each subject will be instructed to inhale from the pocket diffuser beginning on the day of their chemotherapy (Day 1) and continue using the inhaler for the next three consecutive days (Day 1-Day 4).The subjects will remove the cover of the pocket diffuser, place the pocket diffuser approximately an inch away from their nose and inhale three times with deep breathing (i.e., three sniffs). Subjects will take 3 sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening).The subjects will complete a Pre-treatment Assessment form before cycle of chemotherapy (total of 2), as well as 24 and 72 hours after each cycle of chemotherapy. The exact same procedures will be repeated during the participant's next cycle of chemotherapy, which is likely two or three weeks after the first one. |
| Ginger Essential Oil | Active comparator | Other: Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla ExtractUsual care plus a personal pocket diffuser prepared with 14 drops of ginger essential oil. Each subject will be instructed to inhale from the pocket diffuser beginning on the day of their chemotherapy (Day 1) and continue using the inhaler for the next three consecutive days (Day 1-Day 4). The subjects will remove the cover of the pocket diffuser, place the pocket diffuser approximately an inch away from their nose and inhale three times with deep breathing (i.e., three sniffs). Subjects will take 3 sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening). The subjects will complete a Pre-treatment Assessment form before cycle of chemotherapy (total of 2), as well as 24 and 72 hours after each cycle of chemotherapy.The exact same procedures will be repeated during the participant's next cycle of chemotherapy, which is likely two or three weeks after the first one. |
| Pure Vanilla Extract (placebo-control) | Placebo comparator | Other: Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla ExtractUsual care plus a personal pocket diffuser prepared with 14 drops of pure vanilla extract (placebo). Each subject will be instructed to inhale from the pocket diffuser beginning on the day of their chemotherapy (Day 1) and continue using the inhaler for the next three consecutive days (Day 1-Day 4). The subjects will remove the cover of the pocket diffuser, place the pocket diffuser approximately an inch away from their nose and inhale three times with deep breathing (i.e., three sniffs). Subjects will take 3 sniffs of the aromatherapy inhaler three times daily (morning, afternoon, and evening). The subjects will complete a Pre-treatment Assessment form before cycle of chemotherapy (total of 2), as well as 24 and 72 hours after each cycle of chemotherapy. The exact same procedures will be repeated during the participant's next cycle of chemotherapy, which is likely two or three weeks after the first one. |
Who may qualify
- Ages
- 21 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Men and women included
- Ages between 21 years old and 89 years old
- Diagnosis of breast cancer - all histologies and stages
- Subjects must have reported some degree of nausea following chemotherapy
- Subjects must have at least two remaining cycles of chemotherapy to complete
Key exclusion criteria (6 listed)
- Inability to sign the consent
- Pregnancy
- Cognitive impairment
- Current use of aromatherapy for symptom management or prevention
- Allergies to peppermint, ginger, or vanilla
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla ExtractInhaled Aromatherapy via a pocket sized diffuser which contains one of the following:Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract (placebo-control). | Other | Ginger Essential Oil, Peppermint Essential Oil, Pure Vanilla Extract (placebo-control) |
Primary outcome
Acute Nausea Score
Time frame: 24 hours post-chemotherapy
N\&V experienced during the first 24 hours after chemotherapy administration as measured by the Memorial Symptom Assessment Scale's nausea and vomiting dimension with values for symptoms, if experienced, on a 4-point scale; its frequency, if appropriate, on a 4-point scale; and its associated distress on a 5-point categorical scale. The higher the score determines a worse outcome in all areas.
Delayed Nausea Score
Time frame: 72 hours post-chemotherapy
N\&V that occurs more than 24 hours after chemotherapy administration , as measured by the Memorial Symptom Assessment Scale's nausea and vomiting dimension, with values for symptoms, if experienced, on a 4-point scale; its frequency, if appropriate, on a 4-point scale; and its associated distress on a 5-point categorical scale. The higher the score determines a worse outcome in all areas.
4 secondary outcomes
Appetite For the 24 Hours Post-chemotherapy
Time frame: 24 hours post-chemotherapy
Appetite During the 72 Hours Post-chemotherapy
Time frame: 72 hours post-chemotherapy
Use of additional anti-emetic medications (in addition to the standard regimen's listed anti-emetics)
Time frame: 24 hours post-chemotherapy
Use of additional anti-emetic medications (in addition to the standard regimen's listed anti-emetics)
Time frame: 72 hours post-chemotherapy
Results and safety
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: Yes. The Clinical Study Report will be available to other researchers after the study and data are finalized.
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Nausea, Vomiting
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract in people with Nausea and Vomiting, run by Milton S. Hershey Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Investigator left institution). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute Nausea Score (time frame: 24 hours post-chemotherapy). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2023.