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.

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

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

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

Gastrointestinal Cancer

Neuroendocrine Carcinoma

Skin Cancer

Aromatherapy and Essential Oils

Subject Diary

Ohio State University Comprehensive Cancer Center

Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

Inhaled Essential Oil Effect on Common Quality of Life Concerns During Cancer Treatment

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.

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.

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.

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.

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.

Amber Williams

Principal Investigator

National Cancer Institute (NCI)

A cycle of 3 Vichy shower and whirlpool baths are applied during 30-minutes period. Vichy sedative shower is applied for 90-120 sec to the sides of the trunk and the abdomen, avoiding as much as possible the gall bladder area, at a temperature of 36-38ºC. A short, partial jet spray followed the shower. A whirlpool bath is administered where subjects immersed the body until their clavicle level for a 10min period with a water temperature ranging 33.5-35.5 ºC. Aromatherapy application using lavender and chamomile oils is used in all Spa therapy sessions.

The control group perform a rest session in supine position in a room with neutral temperature condition with a same duration to Spa session. Participants of both groups are encouraged to drink water "ad libitum" to prevent dehydration.

Health Behavior

Spa session

Sport Club yo10

Spa Effects After Exercise

SPA THERAPY AS RECOVERY PROCEDURE AFTER EXERCISE: A PRAGMATIC CONTROLLED TRIAL

Dr. Antonio I Cuesta-Vargas

Principal Researcher in Physiotherapy

University of Malaga

Each capsule contains 90 mg dry extract of chamomile flowering tops [6:1 (v/v) extraction solvent (ethanol 70%/30% water): flowering tops] standardized up to 2.5 mg of (-)-α-bisabolol and ≥ 2.5 mg of apigenin per tablet

Placebo Tablet

Chamomile High Grade Extract

Total

Sex: Female, Male

Region of Enrollment

Change from baseline of chamomile extract, three tablets (equivalent to 7.5 g of dried herb) p.o. twice times daily versus placebo on the following sleep measures at 28 days:
the change from baseline of daily self-report of sleep as assessed by a sleep diary that includes determination of: (i) sleep efficiency, which equals "The total sleep time divided by time-in-bed, multiplied by 100." This measure is our primary aim (SE).

Change From Baseline of Chamomile Extract on Measures of Sleep at Day 28.

Change from baseline of chamomile extract, three tablets p.o. twice times daily versus placebo on daytime functioning measures at 28 days:
the change from baseline of measures of depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II), which is scored on a scale of 0 to 63 where a total score of 0-13 is considered minimal range (minimal depression), 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

Change From Baseline of Chamomile on Daytime Functioning Measures: BDI

Change From Baseline of Chamomile on Daytime Functioning Measures, depression and anxiety evaluated respectively with the Beck Depression Inventory-II (BDI-II) and trait portrait of the State Trait Anxiety Index (STAI). STAI scores range for each subtest from 20-80, the higher score indicating greater anxiety. A cut point of 39-40 has been suggested to detect clinically significant symptoms for the S-Anxiety scale

Change From Baseline of Chamomile on Daytime Functioning Measures: STAI

Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale (FSS) Range: 9 to 63. The 9-item scale measures the severity of fatigue and its effect on a person's activities and lifestyle in patients with a variety of disorders.
The minimum score = 9 and maximum score possible = 63. Higher the score = greater fatigue severity.

Change From Baseline of Chamomile on Daytime Functioning Measures: Fatigue Severity Scale

the change from baseline of global QOL (as determined by the 12 Item Short Form Health Survey Version 2 {SF-12 V2})

Change From Baseline of Chamomile on Daytime Functioning Measures [ Time Frame: Baseline and Day 28 ]

Changes from baseline in the safety and tolerability of Chamomile High Grade Extract, three tablets (equivalent to 7.5g of dried herb) p.o. twice times daily versus placebo were measured by counting all participants who reported a serious or non-serious adverse event at the weekly check-ins that were established.

Changes From Baseline in the Safety and Tolerability of Chamomile

Overall Study

Suzanna M Zick

Primary Insomnia

Chronic Insomnia

three tablets each (equivalent to 7.5 g of dried herb) p.o. twice daily for 28 days

matricaria recutita/trötthet

Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

Spa Effects After Exercise

Chamomile for Chronic Primary Insomnia

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