Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

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يتم حفظ الارتباط في الحافظة

الحالةمنجز

الرعاة

Ohio State University Comprehensive Cancer Center

المتعاونون

National Cancer Institute (NCI)

تجربة سريرية: NCT03858855

BioSeek: nct03858855

الكلمات الدالة

نبذة مختصرة

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.

وصف

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.

تواريخ

آخر التحقق:	03/31/2020
تم الإرسال لأول مرة:	02/26/2019
تم إرسال التسجيل المقدر:	02/27/2019
أول نشر:	02/28/2019
تم إرسال آخر تحديث:	04/16/2020
آخر تحديث تم نشره:	04/20/2020
تاريخ بدء الدراسة الفعلي:	02/17/2019
تاريخ الإنجاز الأساسي المقدر:	04/12/2020
التاريخ المتوقع لانتهاء الدراسة:	04/12/2020

حالة أو مرض

Gastrointestinal Cancer

Neuroendocrine Carcinoma

Skin Cancer

التدخل / العلاج

Procedure: Group I (bergamot essential oil)

Procedure: Group II (chamomile essential oil)

Procedure: Group III (ginger essential oil)

Procedure: Group IV (almond essential oil)

Other: Subject Diary

مرحلة

مجموعات الذراع

ذراع	التدخل / العلاج
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: Group I (bergamot essential oil) Use bergamot essential oil
Experimental: Group II (chamomile essential oil) Patients inhale 7 drops of chamomile essential oil and complete journal as in group I.	Procedure: Group II (chamomile essential oil) Use chamomile essential oil
Experimental: Group III (ginger essential oil) Patients inhale 7 drops of ginger essential oil and complete journal as in group I.	Procedure: Group III (ginger essential oil) Use ginger essential oil
Active Comparator: Group IV (almond essential oil) Patients inhale 7 drops of almond essential oil and complete journal as in group I.	Procedure: Group IV (almond essential oil) Use almond essential oil

معايير الأهلية

الأعمار المؤهلة للدراسة	18 Years إلى 18 Years
الأجناس المؤهلة للدراسة	All
يقبل المتطوعين الأصحاء	نعم
المعايير	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

النتيجة

مقاييس النتائج الأولية

1. Effects of essential oils on nausea and anxiety [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.

مقاييس النتائج الثانوية

1. Determine if decreased levels of nausea and/or anxiety effect appetite and/or fatigue [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 [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 [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 [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.

Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

الكلمات الدالة

قلق

فقدان الشهية

essential oil

سرطان

إعياء

غثيان

بابونج

بابونج ألماني

مضاد للسرطان

العلاج الكيميائي