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NCT Number: NCT03858855

Inhaled Essential Oil Effect on Common QOL 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.

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Key information

Conditions

Gastrointestinal Cancer Adenocarcinoma Carcinoma Carcinoma, Neuroendocrine Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Melanoma Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neuroectodermal Tumors Neuroendocrine Carcinoma Neuroendocrine Tumors Nevi and Melanomas Skin Cancer Skin Diseases Skin Neoplasms Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ohio State University Comprehensive Cancer Center

Columbus, Ohio, 43210, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aromatherapy and Essential Oils

Procedure

Use bergamot essential oil

Other names: Aromatherapy

Subject Diary

Other

Complete journal

Other names: Patient Diary, Subj Diary Form, Subject Diary Form

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

Ohio State University Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Mar 1, 2019
Registry last updated
Aug 4, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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