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

NCT04478630 | Terminated

• 1 other identifier: 19-104
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Nausea; Vomiting

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  72 hours post-chemotherapy

Secondary Outcomes (4)

• Appetite For the 24 Hours Post-chemotherapy

  24 hours post-chemotherapy

• Appetite During the 72 Hours Post-chemotherapy

  72 hours post-chemotherapy

• Use of additional anti-emetic medications (in addition to the standard regimen's listed anti-emetics)

  24 hours post-chemotherapy

• Use of additional anti-emetic medications (in addition to the standard regimen's listed anti-emetics)

  72 hours post-chemotherapy

Study Arms (3)

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.

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.

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.

Other: Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract

Interventions

Peppermint Essential Oil, Ginger Essential Oil, or Pure Vanilla Extract OTHER

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).

Ginger Essential Oil; Peppermint Essential Oil; Pure Vanilla Extract (placebo-control)

Eligibility Criteria

• Age: 21 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Milton S. Hershey Medical Center: lead
• Doctors Kienle Center for Humanistic Medicine/Penn State College of Medicine: collaborator

Study Sites (1)

Penn State Cancer Institute

Hershey, Pennsylvania, 17033, United States

Location

MeSH Terms

Conditions

Nausea; Vomiting

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Subjects and all members of the research team will not know which group, either peppermint essential oil, ginger essential oil, or placebo (vanilla extract group), the potential subject would be randomly assigned to as the research team members involved in consenting will open a prefilled envelope to determine the group which will be labeled with the correlating diffuser (A, B, or C).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: July 7, 2020
• First Posted: July 21, 2020
• Study Start: August 30, 2021
• Primary Completion: January 18, 2023
• Study Completion: February 18, 2023
• Last Updated: September 18, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: CSR
• Time Frame: The data will become available after the study results are finalized. This is estimated to occur December 2020.

Locations

US (1)