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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

Men and women included

Subjects must be able to use the pocket diffuser

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 Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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Both men and women can participate.

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You must be able to use the pocket diffuser device.

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You must have experienced some level of nausea after receiving chemotherapy.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 72 hours post-chemotherapy for reporting.

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.

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Milton S. Hershey Medical CenterLead Sponsor

492 Previous Clinical Trials

2,798,810 Total Patients Enrolled

3 Trials studying Vomiting

200 Patients Enrolled for Vomiting

Doctors Kienle Center for Humanistic Medicine/Penn State College of MedicineUNKNOWN

Media Library

Peppermint Essential Oil Clinical Trial Eligibility Overview. Trial Name: NCT04478630 — N/A

Vomiting Research Study Groups: Peppermint Essential Oil, Pure Vanilla Extract (placebo-control), Ginger Essential Oil

Vomiting Clinical Trial 2023: Peppermint Essential Oil Highlights & Side Effects. Trial Name: NCT04478630 — N/A

Peppermint Essential Oil 2023 Treatment Timeline for Medical Study. Trial Name: NCT04478630 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many individuals have registered for participation in this research initiative?

"Indeed, clinicaltrials.gov has verified that this medical trial is still gathering participants which began on August 30th 2021. There have been recent updates to the study and 144 subjects are required across a single location."

Answered by AI

What criteria must a person meet to be eligible for this study?

"For this clinical research, 144 people who suffer from nausea and vomiting as a result of chemotherapy are required. Relevant criteria includes: individuals aged 21 to 89 years old; male or female; diagnosed with breast cancer in any stage or histology; two remaining cycles of chemotherapy necessary for enrolment; capable of using the pocket diffuser device supplied by the trial team; fluent in either English or Spanish language."

Answered by AI

Does this investigation include participants who are over 30 years old?

"Eligibility for this trial requires participants to be between 21 and 89 years old."

Answered by AI

Are new participants being accepted for this medical experiment?

"Yes, the information on clinicialtrials.gov confirms that this trial is actively recruiting participants. The posting first went live on August 30th 2021 and has been revised as recently as September 11th 2022. For successful completion of the study, 144 patients are required to be sourced from a single site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effects of Inhaled Aromatherapy on Chemotherapy Induced Nausea (CINV) and Vomiting

Tasha Messmer 2021. "The Effects of Inhaled Aromatherapy on Chemotherapy Induced Nausea (CINV) and Vomiting". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04478630.