Clinical trial NCT03858855: Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment
Official title: Inhaled Essential Oil Effect on Common Quality of Life Concerns During Cancer Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Gastrointestinal Cancer
Neuroendocrine Carcinoma
Skin Cancer
Keywords: aromatherapy
essential oils
Gastrointestinal Cancer
Neuroendocrine Cancer
Melanoma
skin cancer
Lead sponsor: Ohio State University Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2019-03-01
Enrollment: 248
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Effects of essential oils on nausea and anxiety
timeFrame: Up to 7 days
Secondary outcomes:
measure: Determine if decreased levels of nausea and/or anxiety effect appetite and/or fatigue
timeFrame: Up to 7 days
measure: Acceptability of using a personal inhalation bottle for inhalation of essential oils - ease of use
timeFrame: Up to 7 days
measure: Acceptability of using a personal inhalation bottle for inhalation of essential oils - utilization post study period
timeFrame: Up to 7 days
measure: Acceptability of using a personal inhalation bottle for inhalation of essential oils - perception of benefit of essential oil for symptoms
timeFrame: Up to 7 days
Other outcomes:
Locations:
city: Columbus
country: United States
facility: Ohio State University Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Ohio State University Comprehensive Cancer Center
name: Amber Williams, MSN, RN, OCN
role: PRINCIPAL_INVESTIGATOR
References: