Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

The Ohio State University

Status: Completed

Conditions: Gastrointestinal Cancer; Skin Cancer; Neuroendocrine Carcinoma

Treatments: Procedure: Aromatherapy and Essential Oils; Other: Subject Diary

Study type: Interventional

Funder types: Other

Identifiers

NCT03858855

NCI-2019-00340 (Registry Identifier)

OSU-18136

Details and patient eligibility

About

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.

Full 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.

Enrollment: 248 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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248 participants in 4 patient groups

Group I (bergamot essential oil)

Experimental group

Description:

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.

Treatment:

Other: Subject Diary

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Group II (chamomile essential oil)

Experimental group

Description:

Patients inhale 7 drops of chamomile essential oil and complete journal as in group I.

Treatment:

Other: Subject Diary

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Group III (ginger essential oil)

Experimental group

Description:

Patients inhale 7 drops of ginger essential oil and complete journal as in group I.

Treatment:

Other: Subject Diary

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Group IV (almond essential oil)

Active Comparator group

Description:

Patients inhale 7 drops of almond essential oil and complete journal as in group I.

Treatment:

Other: Subject Diary

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils

Procedure: Aromatherapy and Essential Oils