Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

NCT ID: NCT03858855

Last Updated: 2020-08-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

248 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-18

Study Completion Date

2020-04-13

Brief Summary

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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

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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.

Conditions

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Gastrointestinal Cancer Neuroendocrine Carcinoma Skin Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

Aromatherapy and Essential Oils

Intervention Type PROCEDURE

Use bergamot essential oil

Subject Diary

Intervention Type OTHER

Complete journal

Group II (chamomile essential oil)

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

Group Type EXPERIMENTAL

Aromatherapy and Essential Oils

Intervention Type PROCEDURE

Use chamomile essential oil

Subject Diary

Intervention Type OTHER

Complete journal

Group III (ginger essential oil)

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

Group Type EXPERIMENTAL

Aromatherapy and Essential Oils

Intervention Type PROCEDURE

Use ginger essential oil

Subject Diary

Intervention Type OTHER

Complete journal

Group IV (almond essential oil)

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

Group Type ACTIVE_COMPARATOR

Aromatherapy and Essential Oils

Intervention Type PROCEDURE

Use almond essential oil

Subject Diary

Intervention Type OTHER

Complete journal

Interventions

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Aromatherapy and Essential Oils

Use bergamot essential oil

Intervention Type PROCEDURE

Aromatherapy and Essential Oils

Use chamomile essential oil

Intervention Type PROCEDURE

Aromatherapy and Essential Oils

Use ginger essential oil

Intervention Type PROCEDURE

Aromatherapy and Essential Oils

Use almond essential oil

Intervention Type PROCEDURE

Subject Diary

Complete journal

Intervention Type OTHER

Other Intervention Names

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Aromatherapy Aromatherapy Aromatherapy Aromatherapy Patient Diary Subj Diary Form Subject Diary Form

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ohio State University Comprehensive Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Amber Williams

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Amber Williams, MSN, RN, OCN

Role: PRINCIPAL_INVESTIGATOR

Ohio State University Comprehensive Cancer Center

Locations

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Ohio State University Comprehensive Cancer Center

Columbus, Ohio, United States

Site Status

Countries

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United States

Related Links

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Other Identifiers

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NCI-2019-00340

Identifier Type: REGISTRY

Identifier Source: secondary_id

OSU-18136

Identifier Type: -

Identifier Source: org_study_id

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