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


N/A
7 Years
21 Years
Open (Enrolling)
Both
Brain Tumors, Leukemia, Sarcomas, Neuroblastoma, Lymphoma, Hodgkins Disease

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Trial Information

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


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Supportive Care

Outcome Measure:

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

Outcome Time Frame:

One week after completed chemotherapy

Safety Issue:

No

Principal Investigator

Karen Moody, MD, MS

Investigator Role:

Principal Investigator

Investigator Affiliation:

Montefiore Medical Center

Authority:

United States: Institutional Review Board

Study ID:

08-01-017

NCT ID:

NCT00754286

Start Date:

July 2008

Completion Date:

July 2011

Related Keywords:

  • Brain Tumors
  • Leukemia
  • Sarcomas
  • Neuroblastoma
  • Lymphoma
  • Hodgkins Disease
  • Aromatherapy
  • Brain Neoplasms
  • Hodgkin Disease
  • Leukemia
  • Lymphoma
  • Neuroblastoma
  • Vomiting
  • Sarcoma

Name

Location

Children's Hospital at Montefiore Bronx, New York  10467