Clinical trial NCT00754286: 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
Overall status: COMPLETED
Phase: NA
Conditions: Brain Tumors
Leukemia
Sarcomas
Neuroblastoma
Lymphoma
Hodgkins Disease
Keywords: Aromatherapy
Lead sponsor: Albert Einstein College of Medicine
Sponsor class: OTHER
Collaborators: name: Soothing Scents, Inc.
First posted: 2008-09-17
Enrollment: 132
Sex: ALL
Minimum age (years): 7
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy.
timeFrame: One week after completed chemotherapy
Secondary outcomes:
measure: Effects on anxiety, depression and quality of life in this population
timeFrame: At beginning and at end of chemotherapy cycle
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Children's Hospital at Montefiore
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Karen Moody, MD, MS
role: PRINCIPAL_INVESTIGATOR
References: