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NCT Number: NCT00754286

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

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.

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Key information

Conditions

Brain Tumors Brain Diseases Brain Neoplasms Central Nervous System Diseases Central Nervous System Neoplasms Hematologic Diseases Hemic and Lymphatic Diseases Hodgkin Disease Hodgkins Disease Immune System Diseases Immunoproliferative Disorders Leukemia Lymphatic Diseases Lymphoma Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Connective and Soft Tissue Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Nervous System Diseases Nervous System Neoplasms Neuroblastoma Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral Sarcoma Sarcomas

Age range

7 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aromatherapy Scented Wand

Other

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.

Other names: Soothing Scents, Inc., Quease Ease™, Aromatherapy

Placebo wand

Other

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.

Primary outcomes

  1. Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy.

    Time frame: One week after completed chemotherapy

Secondary outcomes

  1. Effects on anxiety, depression and quality of life in this population

    Time frame: At beginning and at end of chemotherapy cycle

Sponsors and collaborators

Lead sponsor

Albert Einstein College of Medicine

Other

Collaborators

  • Soothing Scents, Inc.

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 17, 2008
Registry last updated
Sep 7, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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