A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer
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|ClinicalTrials.gov Identifier: NCT00754286|
Recruitment Status : Unknown
Verified March 2010 by Montefiore Medical Center.
Recruitment status was: Recruiting
First Posted : September 17, 2008
Last Update Posted : March 5, 2010
|Condition or disease||Intervention/treatment||Phase|
|Brain Tumors Leukemia Sarcomas Neuroblastoma Lymphoma Hodgkins Disease||Other: Aromatherapy Scented Wand Other: Placebo wand||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||132 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Primary Purpose:||Supportive Care|
|Official Title:||A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer|
|Study Start Date :||July 2008|
|Estimated Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||July 2011|
Participants will be given aromatherapy wand at the onset of their chemotherapy treatment.
Other: Aromatherapy Scented Wand
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.
Placebo Comparator: Placebo
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.
Other: Placebo wand
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.
- Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy. [ Time Frame: One week after completed chemotherapy ]
- Effects on anxiety, depression and quality of life in this population [ Time Frame: At beginning and at end of chemotherapy cycle ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00754286
|Contact: Karen Moody, MD, MSfirstname.lastname@example.org|
|Contact: Ruth O Santizo, BAemail@example.com|
|United States, New York|
|Children's Hospital at Montefiore||Recruiting|
|Bronx, New York, United States, 10467|
|Contact: Karen Moody, MD, MS 718-741-2342 firstname.lastname@example.org|
|Contact: Ruth O Santizo, BA 718-741-2342 email@example.com|
|Principal Investigator: Karen Moody, MD, MS|
|Principal Investigator:||Karen Moody, MD, MS||Montefiore Medical Center|