A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer
Primary Purpose
Brain Tumors, Leukemia, Sarcomas
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Aromatherapy Scented Wand
Placebo wand
Sponsored by
About this trial
This is an interventional supportive care trial for Brain Tumors focused on measuring Aromatherapy
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
Sites / Locations
- Children's Hospital at Montefiore
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Aromatherapy
Placebo
Arm Description
Participants will be given aromatherapy wand at the onset of their chemotherapy treatment.
Participants will be given the placebo wand at the onset of their chemotherapy treatment. Placebo wands will look identical to the scented wands but will not contain a scent.
Outcomes
Primary Outcome Measures
Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy.
Secondary Outcome Measures
Effects on anxiety, depression and quality of life in this population
Full Information
NCT ID
NCT00754286
First Posted
September 15, 2008
Last Updated
September 6, 2018
Sponsor
Albert Einstein College of Medicine
Collaborators
Soothing Scents, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00754286
Brief Title
A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer
Official Title
A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
July 2008 (Actual)
Primary Completion Date
July 2011 (Actual)
Study Completion Date
July 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Albert Einstein College of Medicine
Collaborators
Soothing Scents, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Brain Tumors, Leukemia, Sarcomas, Neuroblastoma, Lymphoma, Hodgkins Disease
Keywords
Aromatherapy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
132 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Aromatherapy
Arm Type
Experimental
Arm Description
Participants will be given aromatherapy wand at the onset of their chemotherapy treatment.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will be given the placebo wand at the onset of their chemotherapy treatment. Placebo wands will look identical to the scented wands but will not contain a scent.
Intervention Type
Other
Intervention Name(s)
Aromatherapy Scented Wand
Other Intervention Name(s)
Soothing Scents, Inc., Quease Ease™, Aromatherapy
Intervention Description
The aromatherapy used in this will be Quease Ease™, manufactured by Soothing Scents, Inc. Quease Ease is a blend of lavender, spearmint, ginger, and peppermint soaked into a pad placed within a "wand" dispenser that emits a fragrance when placed within a few inches of the nares. Participants will be given aromatherapy wand at the onset of their chemotherapy treatment. Participants will be instructed how to self-administer the aromatherapy treatment. Specifically, they can hold the wand under their nose and breathe in deeply five times when they feel symptoms of nausea or anxiety.
Intervention Type
Other
Intervention Name(s)
Placebo wand
Intervention Description
Placebo wands will look identical to the scented wands but will not contain a scent. Participants will be given the placebo wand at the onset of their chemotherapy treatment. Participants will be instructed how to self-administer the placebo treatment. Specifically, they can hold the wand under their nose and breathe in deeply five times when they feel symptoms of nausea or anxiety.
Primary Outcome Measure Information:
Title
Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy.
Time Frame
One week after completed chemotherapy
Secondary Outcome Measure Information:
Title
Effects on anxiety, depression and quality of life in this population
Time Frame
At beginning and at end of chemotherapy cycle
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Moody, MD, MS
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Children's Hospital at Montefiore
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer
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