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)

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.

Acute Leukemia

Anorexia

Anxiety

Depression

Dyspnea

Insomnia

Nausea

Pain

Undergo placebo intervention using rose water

Placebo

Questionnaire Administration

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.

Lisa Blackburn

Initially, women will be given 1 multiflavour box of Lillipop samples minus the ginger flavour (4 flavours). Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.
All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol

Initially, women will be given 1 Ginger flavor box of Lillipop samples. Each box contains 24 freezies (20 mL each). Each 20ml contains 80mg of dried ginger root. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 a day and to not have any other popsicles, freezies or other ginger products throughout the duration of the study (7 days). Due ginger's antiemetic property, a maximum daily dose is up to 1000mg/day of dried ginger root powder in pregnancy.They can request an additional box of freezies at each follow-up, as needed.All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol.

Initially, women will be given 1 multiflavour box of Mr. Freeze samples. Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.
All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol

Women will not receive any freezies and will be asked to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days).
All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol

Lillipops Iced Soothies (4 Flavours) (Experimental)

Lillipop Iced Soothies (Ginger Flavour) (Experimental)

Mr. Freeze Freezies (4 Flavours) (Active Comparator)

Natural Course Group (No Intervention)

Total

Sex: Female, Male

Region of Enrollment

To assess the effectiveness of Lillipops in the improvement of NVP symptoms. The primary endpoint of interest is the severity of NVP as compared between the 4 groups, defined according to the PUQE-24 (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy that was developed and validated by Motherisk.

Initially, women will be given 1 multiflavour box of Lillipop samples minus the ginger flavour (4 flavours). Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.
All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol.

Lillipops Iced Soothies (4 Flavours)

Lillipop Iced Soothies (Ginger Flavour)

Initially, women will be given 1 multiflavour box of Mr. Freeze samples. Each box contains 24 freezies (20 mL each), 6 of each flavor. They will be told to eat the freezies as needed to alleviate symptoms, up to a maximum of 12 per day, and to not have any other popsicles, freezies or any ginger products throughout the duration of the study (7 days). They can request an additional multiflavour box of freezies at each follow-up, as needed.
All participants will initially receive counselling and advice by the Motherisk NVP Counsellor about symptom management. This includes advice about dietary, non-medicinal and medical treatments as per the Motherisk NVP protocol
Mr. Freeze freezies contain simulated flavours of watermelon, cherry, blue raspberry and cream soda. However, there have been no reports, studies or claims that they are effective as a remedy for the treatment of NVP.

Mr. Freeze Freezies (4 Flavours)

Natural Course Group

Improvement of Nausea and Vomiting of Pregnancy (NVP)

To assess if there are any changes to concurrent symptoms that may intensify NVP, such as metallic taste or gastrointestinal issues (e.g. heartburn, acid reflux, indigestion and gas). The secondary endpoint of interest is the effect of the 4 groups on the status of concurrent symptoms that may intensify NVP, such as metallic taste or gastroesophageal reflux disease, as well as preference for freezie flavours, according to the PUQE-24 (pregnancy-unique quantification of emesis and nausea) scoring system for nausea and vomiting of pregnancy that was developed and validated by Motherisk.

Concurrent Symptoms

To assess preference for freezie flavours.

Freezie Flavour Preference

Overall Study

Dr Shinya Ito, Principal Investigator

Morning Sickness

Lillipops Iced Soothies are naturally flavoured freezies developed in the United Kingdom for women with morning sickness. They are available in 5 different flavours: grapefruit and tangerine, lemon and mint, chamomile and orange, lime and vanilla, and ginger. The flavours are derived from steam distillation of the peels (grapefruit, tangerine, lemon, orange, lime), mint leaves, and chamomile flowers to release and collect their essential oils. Vanilla pods and ginger are macerated and their resin is used. These flavours were chosen because they may provide relief of symptoms as they are either traditional remedies for NVP, such as ginger, or soothing and refreshing flavours, such as chamomile, vanilla and citrus.

Lillipops Iced Soothies (4 flavours)

There are other commercially available freezies, such as Mr. Freeze. Mr. Freeze freezies contain simulated flavours of watermelon, cherry, blue raspberry and cream soda. However, there have been no reports, studies or claims that they are effective as a remedy for the treatment of NVP.

Mr. Freeze Freezies

Lillipops Iced Soothies are naturally flavoured freezies developed in the United Kingdom for women with morning sickness. They are available in 5 different flavours: grapefruit and tangerine, lemon and mint, chamomile and orange, lime and vanilla, and ginger.The flavours are derived from steam distillation of the peels (grapefruit, tangerine, lemon, orange, lime), mint leaves, and chamomile flowers to release and collect their essential oils. Vanilla pods and ginger are macerated and their resin is used. These flavours were chosen because they may provide relief of symptoms as they are either traditional remedies for NVP, such as ginger, or soothing and refreshing flavours, such as chamomile, vanilla and citrus.

Lillipop Iced Soothies (Ginger flavour)

The Hospital for Sick Children

Freezie Remedy to Alleviate Morning Sickness

Effectiveness of a Natural Non-medicinal Freezie Remedy to Alleviate Morning Sickness

Shinya Ito

Division Head, Clinical Pharmacology and Toxicology

Four parallel groups: 1) Lillipops Group (4 flavours): 2) Ginger Lillipops Group; 3) Mr. Freeze Control Group; 4) Natural Course Group. The main comparison is Group 1 vs Group 3.

A computerized randomization table will be prepared by a third party who is not otherwise involved in the study. After a participant has given consent to enrol in the study, the next participant number in sequence will be assigned and the appropriate corresponding sealed envelope will be opened by the study coordinator, determining which product (if any) the participant will receive. The boxes will be given unique codes depending on whether they contain Lillipops (4 flavours), Ginger Lillipops or Mr. Freeze freezies, and the different flavours will also be coded. Participants will be shown a list of the ingredients that are found in Lillipops and Mr. Freeze freezies to ensure that they do not have allergies or take medications that interact with any ingredient(s) that they may be asked to consume.

Colonic Diseases, Functional

CHT - herbal therapy

Hadassah Medical Organization

Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)

A Phase I, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of a Combination Herbal Therapy (CHT), Versus Placebo in Improving the Overall Quality of Life and Symptoms in Patients With Irritable Bowel Syndrome (IBS)

matricaria chamomilla/mual

Inhaled Essential Oil Effect on Common QOL Concerns During Cancer Treatment

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

Freezie Remedy to Alleviate Morning Sickness

Combination Herbal Therapy (CHT) Versus Placebo in Patients With Irritable Bowel Syndrome (IBS)

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