A Randomized Trial of The Effectiveness of Aromatherapy on Chemotherapy Induced Nausea and Vomiting in Children With Cancer

Not Applicable

Completed

• Conditions: Brain Tumors; Leukemia; Hodgkins Disease; Lymphoma; Sarcomas; Neuroblastoma
• Interventions: Other: Aromatherapy Scented Wand; Other: Placebo wand

• Registration Number: NCT00754286
• Lead Sponsor: Albert Einstein College of Medicine

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.

Study Timeline

• Study Start: 2008-07
• Study First Submitted: 2008-09-15
• Study First Submitted QC: 2008-09-16
• Study First Posted: 2008-09-17
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2018-09
• Last Update Submitted: 2018-09-06
• Last Update Posted: 2018-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 132

Inclusion Criteria

• Patients aged 7-21 with a diagnosis of cancer and will be receiving emetogenic chemotherapy.

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Exclusion Criteria

• Patients allergic to peppermint, ginger or lavender

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Aromatherapy	Aromatherapy Scented Wand	Participants will be given aromatherapy wand at the onset of their chemotherapy treatment.
Placebo	Placebo wand	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.

Primary Outcome Measures

Name	Time	Method
Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy.	One week after completed chemotherapy

Secondary Outcome Measures

Name	Time	Method
Effects on anxiety, depression and quality of life in this population	At beginning and at end of chemotherapy cycle

Trial Locations

Locations (1)

Children's Hospital at Montefiore; 🇺🇸 Bronx, New York, United States