Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment
2 other identifiers
interventional
248
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2019
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 18, 2019
CompletedFirst Submitted
Initial submission to the registry
February 27, 2019
CompletedFirst Posted
Study publicly available on registry
March 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 13, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
April 13, 2020
CompletedAugust 4, 2020
July 1, 2020
1.2 years
February 27, 2019
July 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Determine if decreased levels of nausea and/or anxiety effect appetite and/or fatigue
Up to 7 days
Acceptability of using a personal inhalation bottle for inhalation of essential oils - ease of use
Up to 7 days
Acceptability of using a personal inhalation bottle for inhalation of essential oils - utilization post study period
Up to 7 days
Acceptability of using a personal inhalation bottle for inhalation of essential oils - perception of benefit of essential oil for symptoms
Up to 7 days
Study Arms (4)
Group I (bergamot essential oil)
EXPERIMENTALPatients 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)
EXPERIMENTALPatients inhale 7 drops of chamomile essential oil and complete journal as in group I.
Group III (ginger essential oil)
EXPERIMENTALPatients inhale 7 drops of ginger essential oil and complete journal as in group I.
Group IV (almond essential oil)
ACTIVE COMPARATORPatients inhale 7 drops of almond essential oil and complete journal as in group I.
Interventions
Use bergamot essential oil
Complete journal
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Amber Williams, MSN, RN, OCN
Ohio State University Comprehensive Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 27, 2019
First Posted
March 1, 2019
Study Start
February 18, 2019
Primary Completion
April 13, 2020
Study Completion
April 13, 2020
Last Updated
August 4, 2020
Record last verified: 2020-07
Data Sharing
- IPD Sharing
- Will not share