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

Sponsor
Albert Einstein College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT00754286
Collaborator
Soothing Scents, Inc. (Industry)
132
1
2
36
3.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Aromatherapy Scented Wand
  • Other: Placebo wand
N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
132 participants
Allocation:
Randomized
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
Actual Study Start Date :
Jul 1, 2008
Actual Primary Completion Date :
Jul 1, 2011
Actual Study Completion Date :
Jul 1, 2011

Arms and Interventions

Arm Intervention/Treatment
Experimental: Aromatherapy

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.
Other Names:
  • Soothing Scents, Inc.
  • Quease Ease™
  • Aromatherapy
  • 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.

    Outcome Measures

    Primary Outcome Measures

    1. Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy. [One week after completed chemotherapy]

    Secondary Outcome Measures

    1. Effects on anxiety, depression and quality of life in this population [At beginning and at end of chemotherapy cycle]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    7 Years to 21 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Children's Hospital at Montefiore Bronx New York United States 10467

    Sponsors and Collaborators

    • Albert Einstein College of Medicine
    • Soothing Scents, Inc.

    Investigators

    • Principal Investigator: Karen Moody, MD, MS, Montefiore Medical Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Albert Einstein College of Medicine
    ClinicalTrials.gov Identifier:
    NCT00754286
    Other Study ID Numbers:
    • 08-01-017
    First Posted:
    Sep 17, 2008
    Last Update Posted:
    Sep 7, 2018
    Last Verified:
    Sep 1, 2018
    Keywords provided by Albert Einstein College of Medicine
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 7, 2018