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Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

Primary Purpose

Gastrointestinal Cancer, Neuroendocrine Carcinoma, Skin Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aromatherapy and Essential Oils
Aromatherapy and Essential Oils
Aromatherapy and Essential Oils
Aromatherapy and Essential Oils
Subject Diary
Sponsored by
Ohio State University Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Gastrointestinal Cancer focused on measuring aromatherapy, essential oils, Gastrointestinal Cancer, Neuroendocrine Cancer, Melanoma, skin cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ohio State University Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Group I (bergamot essential oil)

Group II (chamomile essential oil)

Group III (ginger essential oil)

Group IV (almond essential oil)

Arm Description

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.

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

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

Patients inhale 7 drops of almond essential oil and complete journal as in group I.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
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.
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.

Full Information

First Posted
February 27, 2019
Last Updated
July 31, 2020
Sponsor
Ohio State University Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03858855
Brief Title
Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment
Official Title
Inhaled Essential Oil Effect on Common Quality of Life Concerns During Cancer Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
February 18, 2019 (Actual)
Primary Completion Date
April 13, 2020 (Actual)
Study Completion Date
April 13, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ohio State University Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastrointestinal Cancer, Neuroendocrine Carcinoma, Skin Cancer
Keywords
aromatherapy, essential oils, Gastrointestinal Cancer, Neuroendocrine Cancer, Melanoma, skin cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
248 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group I (bergamot essential oil)
Arm Type
Experimental
Arm Description
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.
Arm Title
Group II (chamomile essential oil)
Arm Type
Experimental
Arm Description
Patients inhale 7 drops of chamomile essential oil and complete journal as in group I.
Arm Title
Group III (ginger essential oil)
Arm Type
Experimental
Arm Description
Patients inhale 7 drops of ginger essential oil and complete journal as in group I.
Arm Title
Group IV (almond essential oil)
Arm Type
Active Comparator
Arm Description
Patients inhale 7 drops of almond essential oil and complete journal as in group I.
Intervention Type
Procedure
Intervention Name(s)
Aromatherapy and Essential Oils
Other Intervention Name(s)
Aromatherapy
Intervention Description
Use bergamot essential oil
Intervention Type
Procedure
Intervention Name(s)
Aromatherapy and Essential Oils
Other Intervention Name(s)
Aromatherapy
Intervention Description
Use chamomile essential oil
Intervention Type
Procedure
Intervention Name(s)
Aromatherapy and Essential Oils
Other Intervention Name(s)
Aromatherapy
Intervention Description
Use ginger essential oil
Intervention Type
Procedure
Intervention Name(s)
Aromatherapy and Essential Oils
Other Intervention Name(s)
Aromatherapy
Intervention Description
Use almond essential oil
Intervention Type
Other
Intervention Name(s)
Subject Diary
Other Intervention Name(s)
Patient Diary, Subj Diary Form, Subject Diary Form
Intervention Description
Complete journal
Primary Outcome Measure Information:
Title
Effects of essential oils on nausea and anxiety
Description
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.
Time Frame
Up to 7 days
Secondary Outcome Measure Information:
Title
Determine if decreased levels of nausea and/or anxiety effect appetite and/or fatigue
Description
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.
Time Frame
Up to 7 days
Title
Acceptability of using a personal inhalation bottle for inhalation of essential oils - ease of use
Description
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.
Time Frame
Up to 7 days
Title
Acceptability of using a personal inhalation bottle for inhalation of essential oils - utilization post study period
Description
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.
Time Frame
Up to 7 days
Title
Acceptability of using a personal inhalation bottle for inhalation of essential oils - perception of benefit of essential oil for symptoms
Description
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.
Time Frame
Up to 7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amber Williams, MSN, RN, OCN
Organizational Affiliation
Ohio State University Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ohio State University Comprehensive Cancer Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://cancer.osu.edu
Description
The Jamesline

Learn more about this trial

Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

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