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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified March 2010 by Montefiore Medical Center.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Soothing Scents, Inc.
Information provided by:
Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT00754286
First received: September 15, 2008
Last updated: March 4, 2010
Last verified: March 2010
  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: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:


Further study details as provided by Montefiore Medical Center:

Primary Outcome Measures:
  • Examine the effect of aromatherapy on nausea and vomiting among pediatric oncology patients undergoing chemotherapy. [ Time Frame: One week after completed chemotherapy ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effects on anxiety, depression and quality of life in this population [ Time Frame: At beginning and at end of chemotherapy cycle ] [ Designated as safety issue: No ]

Estimated Enrollment: 132
Study Start Date: July 2008
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   7 Years to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754286

Contacts
Contact: Karen Moody, MD, MS 718-741-2342 kmoody@montefiore.org
Contact: Ruth O Santizo, BA 718-741-2342 rsantizo@montefiore.org

Locations
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         
Sponsors and Collaborators
Montefiore Medical Center
Soothing Scents, Inc.
Investigators
Principal Investigator: Karen Moody, MD, MS Montefiore Medical Center
  More Information

No publications provided

Responsible Party: Karen Moody MD, MS, Montefiore Medical Center
ClinicalTrials.gov Identifier: NCT00754286     History of Changes
Other Study ID Numbers: 08-01-017
Study First Received: September 15, 2008
Last Updated: March 4, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Montefiore Medical Center:
Aromatherapy

Additional relevant MeSH terms:
Brain Neoplasms
Hodgkin Disease
Leukemia
Lymphoma
Neuroblastoma
Vomiting
Sarcoma
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neoplasms by Histologic Type
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Neuroectodermal Tumors, Primitive, Peripheral
Neuroectodermal Tumors, Primitive
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms, Connective and Soft Tissue

ClinicalTrials.gov processed this record on July 29, 2014