Herbal and Botanical

All Drugs and Chemicals

Orange

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

Symptoms and General Pathology

All Conditions

Nausea

Vomiting

Signs and Symptoms, Digestive

Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

ginger

placebo

Julie L. Ryan, PhD, MPH

RATIONALE: Ginger may help reduce or prevent nausea. It is not yet known if antiemetic drugs are more effective with or without ginger in treating nausea caused by chemotherapy.

PURPOSE: This randomized phase II/III trial is studying giving antiemetic drugs together with ginger to see how well they work compared to antiemetic drugs alone in treating nausea in patients who are receiving chemotherapy for cancer.

OBJECTIVES:

* Compare the efficacy of 1 course of ginger vs placebo when administered in regimens containing a 5-hydroxytryptamine type 3 (5-HT3) receptor antagonist antiemetic and dexamethasone (or the equivalent dose of IV methylprednisolone) in controlling chemotherapy-related nausea at course 2 of chemotherapy in patients with cancer.
* Compare the efficacy of 3 different doses of ginger in controlling chemotherapy-related nausea in these patients.
* Determine the adverse effects of ginger when given 3 days before chemotherapy administration in these patients.
* Determine the adverse effects of these antiemetic regimens during the 4 days after chemotherapy.
* Compare the chemotherapy-related anticipatory nausea in patients treated with these antiemetic regimens.
* Compare the quality of life during the 4 days after chemotherapy in patients treated with these antiemetic regimens.
* Compare the chemotherapy-related nausea at course 3 of chemotherapy in these patients after 2 courses of ginger vs placebo.

OUTLINE: This is a randomized, double-blind, placebo-controlled, multicenter study. Patients are stratified according to participating center. Patients are randomized to 1 of 4 treatment arms. Day 1 of each course is defined as the day of chemotherapy administration.

* Placebo: Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
* 0.5g Ginger: Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
* 1.0g Ginger: Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.
* 1.5g Ginger: Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

Patients in each arm also continue receiving their scheduled antiemetic regimen comprising a 5-hydroxytryptamine type-3 (5-HT3) receptor antagonist (ondansetron, granisetron, tropisetron, and dolasetron mesylate) and dexamethasone (DM) (or the equivalent dose of IV methylprednisolone (MePRDL)) on day 1 of courses 2 and 3.

Symptoms are assessed on day -3 to day 1 of courses 2 and 3 and on days 1-4 of courses 1-3.

Quality of life is assessed on day 4 of courses 1-3.

Nausea and vomiting are assessed 4 times daily on days 1-4 of courses 1-3.

PROJECTED ACCRUAL: A total of 706 patients will be accrued for this study within 3 years.

Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer

A Phase II/III Randomized, Controlled Clinical Trial Of Ginger (Zingiber Officinale) For Nausea Caused By Chemotherapy For Cancer

Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the maximum of the Day 1 Evening and Night nausea ratings.

Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of peak acute nausea used as the outcome measure.

Negative values for this outcome are favorable.

Nausea evaluated on a 7-point semantic rating scale anchored by "1" = "Not at all nauseated" and by "7" = "Extremely nauseated." Acute nausea calculated as the average of the Day 1 Evening and Night nausea ratings.

Change from post-intervention (cycle 2 of chemotherapy) - baseline (cycle 1 of chemotherapy) of average acute nausea used as the outcome measure.

Negative values for this outcome are favorable.

National Cancer Institute (NCI)

Gary Morrow

Director, URCC CCOP Research Base

Patients receive oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

placebo: Given orally

Placebo

Patients receive oral low-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

ginger extract: Given orally

placebo: Given orally

0.5g Ginger

Patients receive oral intermediate-dose ginger and oral placebo twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

ginger extract: Given orally

placebo: Given orally

1.0g Ginger

Patients receive oral high-dose ginger twice daily on days -3 to 3 of chemotherapy courses 2 and 3.

ginger extract: Given orally

1.5g Ginger

Total

Age, Continuous

Sex: Female, Male

White

Non-White

Unknown

Race/Ethnicity, Customized

College Grad

H.S. Grad

Some/No HS

Education

Previous surgery

Previous chemotherapy

Previous radiation therapy

Alimentary

Breast

Genitourinary

Gynecologic

Hematologic

Lung

Other

Tumor site

Married

Not Married

Marital status

Average nausea evaluated using a 7-point semantic rating scale anchored by "1" = " Not at all nauseated" and by "7" = "Extremely nauseated."

Baseline average nausea, Day1

Maximum nausea evaluated using a 7-point semantic rating scale anchored by "1" = " Not at all nauseated" and by "7" = "Extremely nauseated."

Baseline nausea at its worst

Quality of life is evaluated using the Functional Assessment of Cancer Therapy-General (FACT-G), a 27-item compilation of questions divided into 4 primary domains: Physical Well-Being (PWB)\[range 0 - 28\], Social Well-Being (SWB)\[range 0 - 28\], Emotional Well-Being (EWB) \[range 0 - 24\], and Functional Well-Being (FWB) \[range 0 - 28\]. Total FACT-G score is a sum of the 4 primary domains \[range 0 - 108\]. The higher the score, the better.

Quality of life(FACT-G)

Two main weaknesses of the study, which should be controlled for in future studies, were not controlling for chemotherapy regimens (i.e., high versus low emetogenic regimens) or the severity level of nausea before enrollment.

Charles E. Heckler, PhD, MS. Research Assistant Professor

H0: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea = 0.

Ha: Mean difference between 0.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)

H0: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea = 0.

Ha: Mean difference between 1.0g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)

H0: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea = 0.

Ha: Mean difference between 1.5g and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)

Placebo vs. Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea = 0.

Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Peak Acute Nausea \> 0. (Two-sided)

Eligible patients 18 years of age or older, able to understand English, diagnosed with cancer, may have received more than one chemotherapy cycle and scheduled for at least three additional cycles; randomization stratified by CCOP site. A computer-generated random numbers table assigned patients to one of four treatment arms.

Change From Baseline of Peak Acute Nausea

H0: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea = 0.

Ha: Mean difference between 0.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)

H0: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea = 0.

Ha: Mean difference between 1.0g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)

H0: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea = 0.

Ha: Mean difference between 1.5g and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)

Placebo vs Any Ginger. H0: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea = 0.

Ha: Mean difference between \[(0.5g +1.0g +1.5g) / 3\] and placebo of change from baseline of Average Acute Nausea \> 0. (Two-sided)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Aromatherapy for Chemotherapy-induced Symptoms	NCT02670941	Chemotherapy Sy...	Ginger Lavender Orange Jojoba	21 Years - 89 Years	University of Rochester
Aromatherapy for Chemotherapy-induced Symptoms	NCT02670941	Chemotherapy Sy...	Ginger Lavender Orange Jojoba	21 Years - 89 Years	University of Rochester
Ginger in Treating Nausea in Patients Receiving Chemotherapy for Cancer	NCT00040742	Nausea Vomiting	ginger placebo	18 Years - 120 Years	University of Rochester

Spots Global Cancer Trial Database for ginger

Every month we try and update this database with for ginger cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for ginger

Every month we try and update this database with for ginger cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for ginger cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.