Brief Summary
Aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety and increase quality of life in cancer patients. Therefore, the proposed study aims to assess the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of life among pediatric oncology patients receiving emetogenic chemotherapy.
Brief Title
A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer
Detailed Description
Nausea and vomiting remain two of the most distressing symptoms to children being treated for cancer. Nausea and vomiting are directly associated with the administration of chemotherapy, due to effects of the chemotherapy on the gastrointestinal mucosa, and certain chemotherapeutic agents, such as cisplatin, are known to be particularly emetogenic. In addition, anticipatory anxiety has been identified as an important patient factor in the development of post-chemotherapy nausea and vomiting. Many drugs have been developed in an effort to diminish nausea and vomiting in children receiving emetogenic chemotherapy and these agents, particularly the 5-hydroxytryptamine receptors, have vastly reduced the amount of nausea and vomiting experienced in this population. However, approximately 50% of children and adolescents still suffer from nausea and/or vomiting even after maximal pharmacological intervention. This suggests that other interventions are needed to further reduce the experienced nausea and vomiting seen in children undergoing chemotherapy. As such, many patients and providers have turned to complementary and alternative medicine (CAM) for the relief of nausea and vomiting. Aromatherapy is one such modality that has demonstrated some degree of effectiveness in adults suffering from nausea and vomiting due to chemotherapy, motion sickness, or postoperatively.
Aromatherapy is an inexpensive and easy therapy to administer to children, and many children can self administer aromatherapy depending on their age and the form of aromatherapy. Aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety and increase quality of life in cancer patients. Therefore, the proposed study aims to assess the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of life among pediatric oncology patients receiving emetogenic chemotherapy.
Aromatherapy is an inexpensive and easy therapy to administer to children, and many children can self administer aromatherapy depending on their age and the form of aromatherapy. Aromatherapy has anecdotally been reported to decrease nausea and vomiting, decrease anxiety and increase quality of life in cancer patients. Therefore, the proposed study aims to assess the effectiveness of aromatherapy versus placebo on nausea, vomiting, anxiety and quality of life among pediatric oncology patients receiving emetogenic chemotherapy.
Categories
Completion Date
Completion Date Type
Actual
Conditions
Brain Tumors
Leukemia
Sarcomas
Neuroblastoma
Lymphoma
Hodgkins Disease
Eligibility Criteria
Inclusion Criteria:
* Patients aged 7-21 with a diagnosis of cancer and will be receiving emetogenic chemotherapy.
Exclusion Criteria:
* Patients allergic to peppermint, ginger or lavender
* Patients aged 7-21 with a diagnosis of cancer and will be receiving emetogenic chemotherapy.
Exclusion Criteria:
* Patients allergic to peppermint, ginger or lavender
Inclusion Criteria
Inclusion Criteria:
* Patients aged 7-21 with a diagnosis of cancer and will be receiving emetogenic chemotherapy.
* Patients aged 7-21 with a diagnosis of cancer and will be receiving emetogenic chemotherapy.
Gender
All
Gender Based
false
Keywords
Aromatherapy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Maximum Age
21 Years
Minimum Age
7 Years
NCT Id
NCT00754286
Org Class
Other
Org Full Name
Albert Einstein College of Medicine
Org Study Id
08-01-017
Overall Status
Completed
Phases
Not Applicable
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer
Primary Outcomes
Outcome Measure
Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy.
Outcome Time Frame
One week after completed chemotherapy
Secondary Outcomes
Outcome Time Frame
At beginning and at end of chemotherapy cycle
Outcome Measure
Effects on anxiety, depression and quality of life in this population
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Maximum Age Number (converted to Years and rounded down)
21
Minimum Age Number (converted to Years and rounded down)
7
Investigators
Investigator Type
Principal Investigator
Investigator Name
Jonathan Gill
Investigator Email
jgill@montefiore.org
Investigator Phone
718-741-2331