Gastrointestinal CancerNCT03858855
Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment
A study testing Aromatherapy and Essential Oils and Subject Diary in people with Gastrointestinal Cancer and Neuroendocrine Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastrointestinal Cancer, Neuroendocrine Carcinoma, Skin Cancer
- What is being tested?
- Aromatherapy and Essential Oils and Subject Diary
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 248 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Feb 2019to 13 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
Official title: 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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Being tested
- Aromatherapy and Essential Oils, Subject Diary
- Keywords
- aromatherapy, essential oils, Gastrointestinal Cancer, Neuroendocrine Cancer, Melanoma, skin cancer
- Medical subject headings
- Gastrointestinal Neoplasms, Carcinoma, Neuroendocrine, Skin Neoplasms, Melanoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aromatherapy and Essential OilsProcedure or surgery
Also called Aromatherapy
Use bergamot essential oil
Aromatherapy and Essential OilsProcedure or surgery
Also called Aromatherapy
Use chamomile essential oil
Aromatherapy and Essential OilsProcedure or surgery
Also called Aromatherapy
Use ginger essential oil
Aromatherapy and Essential OilsProcedure or surgery
Also called Aromatherapy
Use almond essential oil
Subject DiaryOther
Also called Patient Diary, Subj Diary Form, Subject Diary Form
Complete journal
| Study group | Role | What they receive |
|---|---|---|
| Group I (bergamot essential oil) | Experimental | 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. Receives: Procedure: Aromatherapy and Essential Oils; Other: Subject Diary |
| Group II (chamomile essential oil) | Experimental | Patients inhale 7 drops of chamomile essential oil and complete journal as in group I. Receives: Procedure: Aromatherapy and Essential Oils; Other: Subject Diary |
| Group III (ginger essential oil) | Experimental | Patients inhale 7 drops of ginger essential oil and complete journal as in group I. Receives: Procedure: Aromatherapy and Essential Oils; Other: Subject Diary |
| Group IV (almond essential oil) | Active comparator | Patients inhale 7 drops of almond essential oil and complete journal as in group I. Receives: Procedure: Aromatherapy and Essential Oils; Other: Subject Diary |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 7 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2019
- Study start18 Feb 2019
- Primary completion13 Apr 2020
- Study completion13 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
- More trials run by Ohio State University Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 248 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amber Williams, Ohio State University Comprehensive Cancer Center
- Investigators
- Amber Williams, MSN, RN, OCN, Principal investigator, Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03858855
- Sponsor's protocol ID
- OSU-18136
- Other IDs
- NCI-2019-00340
- Status last verified
- Jul 2020
- First submitted
- 27 Feb 2019
- Last updated
- 4 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inhaled Essential Oil Effect on Common Quality of Life Concerns During Cancer Treatment
- ClinicalTrials.gov ID
- NCT03858855
- Acronym / sponsor ID
- OSU-18136
- Keywords
- aromatherapy, essential oils, Gastrointestinal Cancer, Neuroendocrine Cancer, Melanoma, skin cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 248 participants (actual)
- Lead sponsor
- Ohio State University Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 18 Feb 2019 (actual)
- Primary completion
- 13 Apr 2020 (actual)
- Study completion
- 13 Apr 2020 (actual)
- First posted
- 1 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group I (bergamot essential oil) | Experimental | Procedure: Aromatherapy and Essential Oils, Other: Subject DiaryPatients 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. |
| Group II (chamomile essential oil) | Experimental | Procedure: Aromatherapy and Essential Oils, Other: Subject DiaryPatients inhale 7 drops of chamomile essential oil and complete journal as in group I. |
| Group III (ginger essential oil) | Experimental | Procedure: Aromatherapy and Essential Oils, Other: Subject DiaryPatients inhale 7 drops of ginger essential oil and complete journal as in group I. |
| Group IV (almond essential oil) | Active comparator | Procedure: Aromatherapy and Essential Oils, Other: Subject DiaryPatients inhale 7 drops of almond essential oil and complete journal as in group I. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aromatherapy and Essential OilsAlso: AromatherapyUse bergamot essential oil | Procedure or surgery | Group I (bergamot essential oil) |
| Aromatherapy and Essential OilsAlso: AromatherapyUse chamomile essential oil | Procedure or surgery | Group II (chamomile essential oil) |
| Aromatherapy and Essential OilsAlso: AromatherapyUse ginger essential oil | Procedure or surgery | Group III (ginger essential oil) |
| Aromatherapy and Essential OilsAlso: AromatherapyUse almond essential oil | Procedure or surgery | Group IV (almond essential oil) |
| Subject DiaryAlso: Patient Diary, Subj Diary Form, Subject Diary FormComplete journal | Other | Group I (bergamot essential oil), Group II (chamomile essential oil), Group III (ginger essential oil), Group IV (almond essential oil) |
Primary outcome
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.
4 secondary outcomes
Determine if decreased levels of nausea and/or anxiety effect appetite and/or fatigue
Time frame: Up to 7 days
Acceptability of using a personal inhalation bottle for inhalation of essential oils - ease of use
Time frame: Up to 7 days
Acceptability of using a personal inhalation bottle for inhalation of essential oils - utilization post study period
Time frame: Up to 7 days
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2020.
- The JameslineLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amber Williams, MSN, RN, OCN principal investigator
Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aromatherapy and Essential Oils and Subject Diary in people with Gastrointestinal Cancer and Neuroendocrine Carcinoma, run by Ohio State University Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects of essential oils on nausea and anxiety (time frame: Up to 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2020.