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Orange

A total of 40 cancer patients receiving chemotherapy will be recruited as participants in this study. Blood orange and rosewood will be chosen as the essential oils for aromatherapy in this study. Essential oils will be applied to all participants by inhalation for 30 minutes.

essential oils

Chun-Yi Lin, DrPH

Background: Stress is the critical method for survive of reacting to a condition including a threat, challenge or physical and psychological challenge. Stress either physiological or biological is an organism's response to a stressor such as an environmental condition. Stimuli that alter an organism's environment are responded to by multiple systems in the body. The hypothalamic-pituitary-adrenal (HPA) axis and autonomic nervous system are major systems which the body reacts to the stress. It has been reported that cancer patients receiving chemotherapy perceived a lot of stress. It has been believed and well known that stress-related illness is one of the reasons contributing to the increase in long-term sick leave during the last decade in many countries.

Purpose: The aims of this study are to evaluate the effects of aromatherapy on cancer patient receiving chemotherapy: 1) for physical effects by meridian electrical conductance, heart rate variability (HRV), vital sign, visual analogue scale (VAS) for pain; 2) for psychologic effects by State-Trait Anxiety Inventory (STAI).

Materials and methods: This is a prospective, pre post comparison study. A total of 40 cancer patients receiving chemotherapy will be recruited as participants in this study. The characteristics data will be collected in all participants. Blood orange and rosewood will be chosen as the essential oils for aromatherapy in this study. Essential oils will be applied to all participants by inhalation for 30 minutes. Meridian electrical conductance, HRV, vital sign, VAS for pain, and STAI were evaluated and compared before and after aromatherapy.

Expected outcomes: It is expected to understand more about the effects of aromatherapy on the meridian system, HRV and emotional status by undertaking 30 minutes session aromatherapy intervention for cancer patients receiving chemotherapy. The results may suggest aromatherapy as one of the affiliated programs of chemotherapy.

The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy

Visual analogue scale for pain. Scores are recorded between 0 for "no pain" and 10 for "worst pain". A higher score indicates greater pain intensity.

Show Chwan Memorial Hospital

Ginger

English Lavender

Subjects will use the aromatherapy inhalers through three chemotherapy treatment cycles (i.e., Study Cycle 1, Study Cycle 2, and Study Cycle 3). During each Study Cycle, subjects will start the aromatherapy inhaler on the day before the start of their chemotherapy treatment cycle (Day 0) and continue using the inhaler for the next six consecutive days (Day 1-Day 6), including the day he/she starts their chemotherapy treatment cycle. The subjects will remove the cover of the aromatherapy inhaler, place the aromatherapy inhaler under their nose and inhale three times with deep breathing (i.e., three sniffs). After use, the inhaler should be capped to minimize dispersal of the scent. Subjects will take 3 sniffs of the aromatherapy inhaler four times daily (morning, noon, evening, bedtime).

The ginger oil (GIN-106) was steam distilled from fresh ginger grown in Madagascar. The ginger oil contains 64.23% sesquiterpenes, 18.5% monoterpenes, and 3.28% aldehydes. The aroma of ginger is described as spicy, sweet, and warm.

The lavender oil (LAV-110) was steam distilled from lavender grown in Kashmir Valley in India. The lavender oil contains 53.22% esters, 31.86% monoterpenols, and 4.88% oxides. The aroma of lavender is described as floral, fresh, herbaceous, and sweet.

Lavender

The orange oil (ORG-114) was cold-pressed and steam distilled from oranges in South Africa. The orange oil contains 97.21% monoterpenes, 0.73% aldehydes, and 0.7% monoterpenols. The aroma of orange is described as citrus, fresh, fruity, and sweet.

The jojoba oil is certified organic and pesticide-free pure oil. Jojoba has a mild scent and can be used as a "fixative" for other essential oils.

Jojoba

Julie Ryan, PhD, MPH

The rationale behind the proposed study is to determine the initial effectiveness of aromatherapy in relief of commonly reported symptoms in cancer patients undergoing chemotherapy.

The proposed study is an exploratory trial to evaluate the use of aromatherapy for symptom management in patients undergoing chemotherapy. The investigators will accrue 120 adult cancer subjects undergoing chemotherapy in a initial efficacy study to determine the effectiveness of three different aromatherapies (ginger, lavender, or orange) on chemotherapy-related symptoms (nausea, vomiting, pain, anxiety, sleep difficulties, fatigue, and lack of appetite) compared to placebo (i.e., jojoba). All subjects will be randomized to one of the four arms for symptom management during three different chemotherapy cycles. The investigators will examine the incidence and severity of the seven symptoms at each chemotherapy cycle. The preliminary data from this study will elucidate the relationships between certain aromatherapies and specific symptom relief, which can be further evaluated in a larger confirmatory study of subjects undergoing chemotherapy or other types of cancer treatment. This study will provide clinical evidence regarding the incorporation of aromatherapy into cancer patient care.

Aromatherapy for Chemotherapy-induced Symptoms

Aromatherapy for Management of Chemotherapy-induced Symptoms

Subjects will complete a self-report Symptom Inventory Diary during each Study Cycle starting at Day 0 and continuing to Day 6. Subjects will rate the severity of seven symptoms (nausea, vomiting, pain, anxiety/distress, sleep difficulties, fatigue, and lack of appetite) using a 0-10 numeric rating scale, with 10 indicating a higher severity, in daily diary format.

The following questions will be asked of the subjects to obtain qualitative feedback to further evaluate acceptability of the aromatherapy inhalers: 1) What two things did you like about your aromatherapy inhaler?; 2) What two things did subjects dislike about the aromatherapy inhaler?; 3) Was the aromatherapy inhaler easy to use?; 4) Did subjects feel that the aromatherapy inhaler reduced symptoms from chemotherapy? Please circle the symptoms that seemed to be helped the most.; 5) Would the subject use this aromatherapy inhaler again in the future?; 6) Would the subject recommend this aromatherapy inhaler to others?; 7) What word or statement would the subject use to describe their experience during this clinical trial?; and 8) What intervention arm do subjects think they were in? All of these data will help determine if the aromatherapy inhalers and scents are acceptable and feasible to use for in cancer subjects during chemotherapy.

University of Rochester

Assistant Professor of Dermatology

Neoplasms

Skin and Connective Tissue Diseases

Nervous System Diseases

Breast Neoplasms

Peripheral Nervous System Diseases

Breast Diseases

Skin Diseases

Neuromuscular Diseases

Anti-Infective Agents

Antitussive Agents

Respiratory System Agents

Turmeric extract

Eucalyptol

Turmeric

Peppermint

Rosemary

10% dilution of Curcuma longa, Piper nigrum, Pelargonium asperum, Zingiber officinale, Mentha x piperita, and Rosmarinus officinalis ct. cineole in Simmondsia chinensis

Placebo

Julie K Zadinsky, PhD

This study will evaluate an oil blend with active ingredients for the reduction in chemotherapy-induced peripheral neuropathy in people with breast cancer. Half of the participants will receive the oil blend with active ingredients and the other half will receive a placebo (an oil blend with no active ingredients). One-fourth of the people will also take pictures of their life with chemotherapy-induced peripheral neuropathy.

Chemotherapy-induced peripheral neuropathy (CIPN) is a painful, debilitating consequence of cancer treatment and is considered the most adverse of non-hematologic events. Current pharmacological approaches to reduce CIPN symptoms can be ineffective and cause adverse effects.

Constituents of this oil blend moderate pain signal transmission through non-competing inhibition of 5-HT, AchE, and Substance P, along with antagonism of TRPA1 and TRPV1. This study will test the hypothesis that an oil blend reduces CIPN symptoms and improves quality-of-life (QOL) in breast cancer patients. The Human Response to Illness model is used to underpin a convergent-nested-parallel mixed-methods design with intervention.

The study design uses a randomized, single-blind, placebo-controlled quantitative (QUAN) strand paralleled by a photovoice methodology qualitative (QUAL) strand.

Participants will be seen in two separate clinic rooms. Intervention and placebo will have identical packaging and labeling with the addition of an A or B.

Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention

Essential Oils Effect on Chemotherapy-Induced Peripheral Neuropathy in Breast Cancer: A Mixed Methods Study

The following two questions are exploratory: In the past seven days, how many times have you slept through the night? In the past seven days, how many times did your pain wake you from sleep? If pain woke you from sleep, please describe your experience. If anything other than pain woke you from sleep, please list. Neither QOL questionnaire also address sleep. The answers to these questions will be integrated into QOL data.

A 22-item self-report pain intensity (over past week) peripheral neuropathy questionnaire. Each item is scored from 0 -10 (0 is no pain and 10 is the worst possible pain), a mean score is obtained, yielding a mean score between 0 and 10.

A 10 cm horizontal line with a 0 (no pain) on the far left and 10 (worst possible pain) on the far right. Participants rate current pain intensity by drawing a mark on the line. Pain intensity is obtained by measuring from the 0 to the participant's mark on the line, yielding a score from 0 to 10. Daily pain scores will be averaged for a weekly mean.

The QLACS consists of 47 questions in two domains (generic and cancer-specific). The questionnaire offers respondents the following choices: 1=never, 2=seldom, 3=sometimes, 4=about as often as not, 5=frequently, 6=very often, and 7=always, yielding a total score of between 0 to 350. A mean score will be used.

The QOL: CIPN20 consists of 20 questions represented by three scales: autonomic symptoms and functioning, sensory, and motor. Participants are to rate symptoms over the past week as 1=not at all, 2=a little, 3=quite a bit, and 4=very much. Items are scored per scale as a higher score = worse, yielding a total score of between 0 and 100. A mean score will be used.

American Holistic Nurses Association

American Nurses Foundation

Ananda Apothecary

The Jojoba Company

Augusta University

Blood and Lymph Conditions

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Rare Diseases

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Sleep Initiation and Maintenance Disorders

Acute Disease

Neoplasms by Histologic Type

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Sleep Disorders, Intrinsic

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Sleep Wake Disorders

Mental Disorders

Psychotic Disorders

Signs and Symptoms, Digestive

Respiration Disorders

Respiratory Tract Diseases

Signs and Symptoms, Respiratory

Disease Attributes

Acute Graft Versus Host Disease

Chamomile

Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2.

Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.

Aromatherapy and Essential Oils

Undergo placebo intervention using rose water

Questionnaire Administration

Lisa Blackburn, MS,RN,AOCNS

This randomized clinical trial studies aromatherapy and essential oils in improving insomnia and other symptoms in patients with newly diagnosed acute leukemia. Aromatherapy and essential oils may help improve insomnia and other complications caused by chemotherapy.

PRIMARY OBJECTIVES:

I. Does the addition of aromatherapy by diffusion of essential oils improve insomnia in newly diagnosed, hospitalized leukemia patients?

SECONDARY OBJECTIVES:

I. Does the addition of aromatherapy by diffusion of essential oils improve other common symptoms in newly diagnosed, hospitalized leukemia patients, including pain, nausea, lack of appetite, shortness of breath, depression, anxiety and wellbeing? II. Do newly diagnosed, hospitalized leukemia patients find the use of aromatherapy for symptom management a positive experience?

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients select between 3 scented essential oils: peppermint, lavender, or chamomile which is diffused in the hospital room from approximately 9 PM in the evening until morning during week 1 and placebo intervention using rose water during week 2.

GROUP II: Patients undergo placebo intervention using rose water during week 1 and aromatherapy and essential oils as in Group I during week 2.

Aromatherapy and Essential Oils in Improving Insomnia and Other Symptoms in Patients With Newly Diagnosed Acute Leukemia Undergoing Chemotherapy

The Effect of Aromatherapy on Insomnia and Other Common Cancer Patient Symptoms

Statistical analysis will be performed using a mixed effects linear regression model. This model is designed to test the effects of interest (i.e., the effect of aromatherapy relative to baseline and to placebo) while accounting for the within-subject correlation arising from the repeated measures design. A 20% positive change in PSQI score will be seen as significant.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy	NCT04826601	Pain Heart Rate Vari... Anxiety	essential oils	20 Years - 70 Years	Show Chwan Memorial Hospital
Aromatherapy for Chemotherapy-induced Symptoms	NCT02670941	Chemotherapy Sy...	Ginger Lavender Orange Jojoba	21 Years - 89 Years	University of Rochester
Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention	NCT03449303	Breast Cancer Peripheral Neur...	EOI Placebo	21 Years -	Augusta University
Aromatherapy for Chemotherapy-induced Symptoms	NCT02670941	Chemotherapy Sy...	Ginger Lavender Orange Jojoba	21 Years - 89 Years	University of Rochester
Aromatherapy and Essential Oils in Improving Insomnia and Other Symptoms in Patients With Newly Diagnosed Acute Leukemia Undergoing Chemotherapy	NCT02445378	Acute Leukemia Anorexia Anxiety Depression Dyspnea Insomnia Nausea Pain	Aromatherapy an... Placebo Questionnaire A...	-	Ohio State University Comprehensive Cancer Center
The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy	NCT04826601	Pain Heart Rate Vari... Anxiety	essential oils	20 Years - 70 Years	Show Chwan Memorial Hospital
Chemotherapy-Induced Peripheral Neuropathy-Essential Oil Intervention	NCT03449303	Breast Cancer Peripheral Neur...	EOI Placebo	21 Years -	Augusta University
The Physical and Psychologic Effects of Aromatherapy in Cancer Patients During Chemotherapy	NCT04826601	Pain Heart Rate Vari... Anxiety	essential oils	20 Years - 70 Years	Show Chwan Memorial Hospital

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