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| Sponsor: | Montefiore Medical Center |
|---|---|
| Collaborators: |
Rady Children's Hospital, San Diego Soothing Scents, Inc. |
| Information provided by: | Montefiore Medical Center |
| ClinicalTrials.gov Identifier: | NCT00754286 |
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.
| Condition | Intervention |
|---|---|
|
Brain Tumors Leukemia Sarcomas Neuroblastoma Lymphoma Hodgkins Disease |
Other: Aromatherapy Scented Wand Other: Placebo wand |
| Study Type: | Interventional |
| Study Design: | Supportive Care, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study |
| Official Title: | A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer |
| Estimated Enrollment: | 132 |
| Study Start Date: | July 2008 |
| Estimated Primary Completion Date: | July 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Aromatherapy: Experimental
Participants will be given aromatherapy wand at the onset of their chemotherapy treatment.
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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.
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Placebo: Placebo Comparator
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.
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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.
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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.
Eligibility| Ages Eligible for Study: | 7 Years to 21 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Karen Moody, MD, MS | 718-741-2342 | kmoody@montefiore.org |
| Contact: Ruth O Santizo, BA | 718-741-2342 | rsantizo@montefiore.org |
| United States, New York | |
| Children's Hospital at Montefiore | Recruiting |
| Bronx, New York, United States, 10467 | |
| Contact: Karen Moody, MD, MS 718-741-2342 kmoody@montefiore.org | |
| Contact: Ruth O Santizo, BA 718-741-2342 rsantizo@montefiore.org | |
| Principal Investigator: Karen Moody, MD, MS | |
| Principal Investigator: | Karen Moody, MD, MS | Montefiore Medical Center |
More Information
| Responsible Party: | Montefiore Medical Center ( Karen Moody MD, MS ) |
| Study ID Numbers: | 08-01-017 |
| Study First Received: | September 15, 2008 |
| Last Updated: | February 14, 2009 |
| ClinicalTrials.gov Identifier: | NCT00754286 History of Changes |
| Health Authority: | United States: Institutional Review Board |
|
Aromatherapy |
|
Neuroectodermal Tumors, Primitive Neoplasms, Nerve Tissue Central Nervous System Neoplasms Brain Diseases Neuroblastoma Neoplasms, Connective and Soft Tissue Leukemia Neoplasms by Site Neoplasms, Germ Cell and Embryonal Lymphoma Hodgkin Disease Nervous System Neoplasms Neoplasms by Histologic Type |
Immunoproliferative Disorders Immune System Diseases Nervous System Diseases Central Nervous System Diseases Brain Neoplasms Lymphatic Diseases Neuroectodermal Tumors Neoplasms Sarcoma Lymphoproliferative Disorders Neoplasms, Neuroepithelial Neuroectodermal Tumors, Primitive, Peripheral Neoplasms, Glandular and Epithelial |