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Peppermint Essential Oil for Vomiting (CINV Trial)
N/A
Waitlist Available
Research Sponsored by Milton S. Hershey Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 72 hours post-chemotherapy
Awards & highlights
CINV Trial Summary
This trial is testing whether using a diffuser with ginger, peppermint, or vanilla extract can help reduce chemotherapy side effects.
Eligible Conditions
- Vomiting
- Nausea
CINV Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 72 hours post-chemotherapy
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~72 hours post-chemotherapy
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acute Nausea Score
Delayed Nausea Score
Secondary outcome measures
Appetite During the 72 Hours Post-chemotherapy
Appetite For the 24 Hours Post-chemotherapy
Use of additional anti-emetic medications (in addition to the standard regimen's listed anti-emetics)
CINV Trial Design
3Treatment groups
Active Control
Placebo Group
Group I: Peppermint Essential OilActive Control1 Intervention
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.
Group II: Ginger Essential OilActive Control1 Intervention
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.
Group III: Pure Vanilla Extract (placebo-control)Placebo Group1 Intervention
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.
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Who is running the clinical trial?
Milton S. Hershey Medical CenterLead Sponsor
497 Previous Clinical Trials
2,799,958 Total Patients Enrolled
3 Trials studying Vomiting
200 Patients Enrolled for Vomiting
Doctors Kienle Center for Humanistic Medicine/Penn State College of MedicineUNKNOWN
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Eligibility Criteria:
This trial includes the following eligibility criteria:- Both men and women can participate.You are currently receiving radiation therapy.You must be able to use the pocket diffuser device.You are pregnant.You have problems with thinking, understanding, or memory.You are allergic to peppermint, ginger, or vanilla.You are currently using aromatherapy to manage or prevent symptoms.You must have experienced some level of nausea after receiving chemotherapy.
Research Study Groups:
This trial has the following groups:- Group 1: Peppermint Essential Oil
- Group 2: Pure Vanilla Extract (placebo-control)
- Group 3: Ginger Essential Oil
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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