Expired Study
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Bronx, New York 10467


Purpose:

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.


Study summary:

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.


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


Study is Available At:


Original ID:

08-01-017


NCT ID:

NCT00754286


Secondary ID:


Study Acronym:


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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

7 Years


Maximum Age:

21 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Albert Einstein College of Medicine, Inc.


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

132


Enrollment Type:

Actual


Overall Contact Information

Official Name:Karen Moody, MD, MS
Principal Investigator
Montefiore Medical Center

Study Dates

Start Date:July 2008
Completion Date:July 2011
Completion Type:Actual
Primary Completion Date:July 2011
Primary Completion Type:Actual
Verification Date:September 2018
Last Changed Date:September 6, 2018
First Received Date:September 15, 2008

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Effects on anxiety, depression and quality of life in this population
Time Frame:At beginning and at end of chemotherapy cycle
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy.
Time Frame:One week after completed chemotherapy
Safety Issues:False

Study Interventions

Intervention Type:Other
Name:Aromatherapy Scented Wand
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 the
Arm Name:Aromatherapy
Other Name:Soothing Scents, Inc.
Intervention Type:Other
Name:Placebo wand
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.
Arm Name:Placebo

Study Arms

Study Arm Type:Experimental
Arm Name:Aromatherapy
Description:Participants will be given aromatherapy wand at the onset of their chemotherapy treatment.
Study Arm Type:Placebo Comparator
Arm Name:Placebo
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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Albert Einstein College of Medicine, Inc.
Agency Class:Industry
Agency Type:Collaborator
Agency Name:Soothing Scents, Inc.

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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