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Trial record 2 of 238 for:    essential oil

Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

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ClinicalTrials.gov Identifier: NCT03858855
Recruitment Status : Enrolling by invitation
First Posted : March 1, 2019
Last Update Posted : April 22, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Amber Williams, Ohio State University Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Gastrointestinal Cancer Neuroendocrine Carcinoma Melanoma Procedure: Aromatherapy and Essential Oils Other: Subject Diary Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 267 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Inhaled Essential Oil Effect on Common Quality of Life Concerns During Cancer Treatment
Actual Study Start Date : February 18, 2019
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


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 Name: 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 chamomile essential oil
Other Name: 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 ginger essential oil
Other Name: 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 almond essential oil
Other Name: Aromatherapy

Other: Subject Diary
Complete journal
Other Names:
  • Patient Diary
  • Subj Diary Form
  • Subject Diary Form




Primary Outcome Measures :
  1. Effects of essential oils on nausea and anxiety [ Time Frame: Up to 7 days ]
    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 :
  1. Determine if decreased levels of nausea and/or anxiety effect appetite and/or fatigue [ Time Frame: Up to 7 days ]
    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.

  2. Acceptability of using a personal inhalation bottle for inhalation of essential oils - ease of use [ Time Frame: Up to 7 days ]
    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.

  3. Acceptability of using a personal inhalation bottle for inhalation of essential oils - utilization post study period [ Time Frame: Up to 7 days ]
    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.

  4. Acceptability of using a personal inhalation bottle for inhalation of essential oils - perception of benefit of essential oil for symptoms [ Time Frame: Up to 7 days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Gastrointestinal cancers, neuroendocrine cancer, or melanoma
  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03858855


Locations
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United States, Ohio
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, United States, 43210
Sponsors and Collaborators
Ohio State University Comprehensive Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Amber Williams, MSN, RN, OCN Ohio State University Comprehensive Cancer Center

Additional Information:
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Responsible Party: Amber Williams, Principal Investigator, Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03858855     History of Changes
Other Study ID Numbers: OSU-18136
NCI-2019-00340 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
P30CA016058 ( U.S. NIH Grant/Contract )
First Posted: March 1, 2019    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Amber Williams, Ohio State University Comprehensive Cancer Center:
aromatherapy
essential oils
Gastrointestinal Cancer
Neuroendocrine Cancer
Melanoma
Additional relevant MeSH terms:
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Melanoma
Gastrointestinal Neoplasms
Carcinoma, Neuroendocrine
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas
Digestive System Neoplasms
Neoplasms by Site
Digestive System Diseases
Gastrointestinal Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial