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

NCT00754286 | Completed DMC

• 1 other identifier: 08-01-017
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Tumors; Leukemia; Sarcomas; Neuroblastoma; Lymphoma; Hodgkins Disease

Keywords

Aromatherapy

Outcome Measures

Primary Outcomes (1)

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

  One week after completed chemotherapy

Secondary Outcomes (1)

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

  At beginning and at end of chemotherapy cycle

Study Arms (2)

Aromatherapy

EXPERIMENTAL

Participants will be given aromatherapy wand at the onset of their chemotherapy treatment.

Other: Aromatherapy Scented Wand

Placebo

PLACEBO COMPARATOR

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

Interventions

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.

Also known as: Soothing Scents, Inc., Quease Ease™, Aromatherapy

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.

Placebo

Eligibility Criteria

• Age: 7 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Patients allergic to peppermint, ginger or lavender

Sponsors & Collaborators

• Albert Einstein College of Medicine: lead
• Soothing Scents, Inc.: collaborator

Study Sites (1)

Children's Hospital at Montefiore

The Bronx, New York, 10467, United States

Location

MeSH Terms

Conditions

Brain Neoplasms; Leukemia; Sarcoma; Neuroblastoma; Lymphoma; Hodgkin Disease

Interventions

Aromatherapy

Condition Hierarchy (Ancestors)

Central Nervous System Neoplasms; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Neoplasms, Connective and Soft Tissue; Neuroectodermal Tumors, Primitive, Peripheral; Neuroectodermal Tumors, Primitive; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Phytotherapy; Sensory Art Therapies; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Karen Moody, MD, MS

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2008
• First Posted: September 17, 2008
• Study Start: July 1, 2008
• Primary Completion: July 1, 2011
• Study Completion: July 1, 2011
• Last Updated: September 7, 2018

Record last verified: 2018-09

Locations

US (1)