Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

Inhaled Essential Oil Effect on Common Quality of Life Concerns During Cancer Treatment

This single-blind, randomized controlled trial studies how well inhaled essential oils work for common quality of life concerns in patients who are undergoing cancer treatment such as chemotherapy, targeted therapy, and/or immunotherapy given through the vein (intravenously). Aromatherapy using essential oils, such as ginger essential oil, German chamomile essential oil, and bergamot essential oil, may improve quality of life issues such as nausea, anxiety, loss of appetite, and fatigue in patients undergoing treatment for cancer.

Study Overview

• Status: Completed
• Conditions: Skin Cancer; Gastrointestinal Cancer; Neuroendocrine Carcinoma
• Intervention / Treatment: Procedure: Aromatherapy and Essential Oils; Procedure: Aromatherapy and Essential Oils; Procedure: Aromatherapy and Essential Oils; Procedure: Aromatherapy and Essential Oils; Other: Subject Diary

Detailed Description

PRIMARY OBJECTIVES:

I. To determine if aromatherapy, specifically inhaled essential oil, is beneficial for side effects related to cancer treatments involving chemotherapy, targeted therapy, and/or immunotherapy administered intravenously.

II. To describe the effect of inhaled ginger essential oil, German chamomile essential oil, and bergamot essential oil on nausea and anxiety of patients receiving chemotherapy, targeted therapy, and/or immunotherapy administered intravenously.

III. To describe the effect of decreased levels of nausea and/or anxiety on levels of appetite and/or fatigue.

IV. To evaluate the acceptability of using a personal inhalation bottle for inhalation of essential oils.

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP I: Patients inhale 7 drops of bergamot essential oil using a personalized inhalation bottle three times daily (TID) (morning, midday, and evening) for up to 7 days. Patients also use a journal to document symptoms, time of inhalation, and medication use TID for up to 7 days.

GROUP II: Patients inhale 7 drops of chamomile essential oil and complete journal as in group I.

GROUP III: Patients inhale 7 drops of ginger essential oil and complete journal as in group I.

GROUP IV (CONTROL): Patients inhale 7 drops of almond essential oil and complete journal as in group I.

• Study Type: Interventional
• Enrollment (Actual): 248
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Columbus, Ohio, United States, 43210
      • Ohio State University Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Gastrointestinal cancers, neuroendocrine cancer, or melanoma or other skin cancers
• Receiving chemotherapy, targeted therapy, and/or immunotherapy
• Not naive to the treatment
• Must be able to read and write English

Exclusion Criteria:

• Allergies to ragweed, chrysanthemum, chamomile, ginger, bergamot, citrus fruits, tree nuts, perfumes
• Asthma diagnosis
• Patients receiving only octreotide injections
• Patients receiving floxuridine (FUDR) via hepatic artery infusion (HAI) pump only

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I (bergamot essential oil); Patients inhale 7 drops of bergamot essential oil using an essential oil administration bottle TID (morning, midday, and evening) for up to 7 days. Patients also use a journal to document symptoms, time of inhalation, and medication use TID for up to 7 days.	Procedure: Aromatherapy and Essential Oils; Use bergamot essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use chamomile essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use ginger essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use almond essential oil; Other Names: Aromatherapy; Other: Subject Diary; Complete journal; Other Names: Patient Diary; Subj Diary Form; Subject Diary Form
Experimental: Group II (chamomile essential oil); Patients inhale 7 drops of chamomile essential oil and complete journal as in group I.	Procedure: Aromatherapy and Essential Oils; Use bergamot essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use chamomile essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use ginger essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use almond essential oil; Other Names: Aromatherapy; Other: Subject Diary; Complete journal; Other Names: Patient Diary; Subj Diary Form; Subject Diary Form
Experimental: Group III (ginger essential oil); Patients inhale 7 drops of ginger essential oil and complete journal as in group I.	Procedure: Aromatherapy and Essential Oils; Use bergamot essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use chamomile essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use ginger essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use almond essential oil; Other Names: Aromatherapy; Other: Subject Diary; Complete journal; Other Names: Patient Diary; Subj Diary Form; Subject Diary Form
Active Comparator: Group IV (almond essential oil); Patients inhale 7 drops of almond essential oil and complete journal as in group I.	Procedure: Aromatherapy and Essential Oils; Use bergamot essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use chamomile essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use ginger essential oil; Other Names: Aromatherapy; Procedure: Aromatherapy and Essential Oils; Use almond essential oil; Other Names: Aromatherapy; Other: Subject Diary; Complete journal; Other Names: Patient Diary; Subj Diary Form; Subject Diary Form

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Effects of essential oils on nausea and anxiety	Levels of nausea and anxiety will be measured using a numerical grading scale of 0-10. 0 will equal "good" meaning no nausea or anxiety. 10 will equal "horrible" meaning the worst nausea or anxiety. Data for each outcome will be collected 3 times a day, for a total of 21 measurements from each subject. For data analysis, we will compress the 21 measures into 3 scores. Each subject will be given a daily outcome level by averaging the 3 measures. The 7 daily outcome levels will become 3 scores by averaging data from days 1 and 2 (Period 1), days 3 and 4 (Period 2), and days 5, 6, and 7 (Period 3). Using the 3 scores, each outcome will be modeled using a repeated measures regression allowing the variability of outcome scores to vary with period. Period, group membership, the interaction between period and group membership, gender, age, and type of cancer will be model predictors. For each outcome, the contrast of interest will be that between each treatment group and the control group.	Up to 7 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Determine if decreased levels of nausea and/or anxiety effect appetite and/or fatigue	Anticipated results of the study are that patients will report decreased levels of nausea and anxiety. With the decreased levels of nausea and anxiety, we anticipate that patients will report increased levels of appetite and decreased levels of fatigue. Loss of appetite and fatigue will be measured using a numerical grading scale of 0-10. 0 will equal "good" meaning no loss of appetite or fatigue. 10 will equal "horrible" meaning the worst appetite loss or fatigue. Data will be collected, measured, and analyzed in the same manner as Outcome 1.	Up to 7 days
Acceptability of using a personal inhalation bottle for inhalation of essential oils - ease of use	The overall ease of using the personal inhalation bottle will be measured through post-study ratings by participants. A numerical rating scale of 1-5 will be used. 1 will equal strongly disagree; 2 will equal disagree; 3 will equal neither agree nor disagree; 4 will equal agree; and 5 will equal strongly agree. The study will compare via a percentage those participants with positive acceptability when compared to those with negative acceptability.	Up to 7 days
Acceptability of using a personal inhalation bottle for inhalation of essential oils - utilization post study period	The utilization of the personal inhalation bottle beyond the study period will be measured through post-study ratings by participants. A numerical rating scale of 1-5 will be used. 1 will equal strongly disagree; 2 will equal disagree; 3 will equal neither agree nor disagree; 4 will equal agree; and 5 will equal strongly agree. The study will compare via a percentage those participants with positive acceptability when compared to those with negative acceptability.	Up to 7 days
Acceptability of using a personal inhalation bottle for inhalation of essential oils - perception of benefit of essential oil for symptoms	The overall perception of help for symptoms will be measured through post-study ratings by participants. A numerical rating scale of 1-5 will be used. 1 will equal strongly disagree; 2 will equal disagree; 3 will equal neither agree nor disagree; 4 will equal agree; and 5 will equal strongly agree. The study will compare via a percentage those participants with positive acceptability when compared to those with negative acceptability.	Up to 7 days

Collaborators and Investigators

• Sponsor: Ohio State University Comprehensive Cancer Center
• Investigators: Principal Investigator: Amber Williams, MSN, RN, OCN, Ohio State University Comprehensive Cancer Center

Publications and helpful links

Helpful Links

• The Jamesline

Study record dates

Study Major Dates

• Study Start (Actual): February 18, 2019
• Primary Completion (Actual): April 13, 2020
• Study Completion (Actual): April 13, 2020

Study Registration Dates

• First Submitted: February 27, 2019
• First Submitted That Met QC Criteria: February 28, 2019
• First Posted (Actual): March 1, 2019

Study Record Updates

• Last Update Posted (Actual): August 4, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: aromatherapy; Melanoma; Gastrointestinal Cancer; essential oils; skin cancer; Neuroendocrine Cancer
• Additional Relevant MeSH Terms: Digestive System Diseases; Skin Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Gastrointestinal Diseases; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Nerve Tissue; Neuroendocrine Tumors; Gastrointestinal Neoplasms; Skin Neoplasms; Carcinoma, Neuroendocrine
• Other Study ID Numbers: OSU-18136; NCI-2019-00340 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No