Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy

Completed · Not applicable · Has a placebo group

Conditions studied: Central Nervous System Tumor, Pediatric, Chemotherapy-induced Nausea and Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific

In brief

RATIONALE: Acupressure wristbands may prevent or reduce nausea and caused by chemotherapy. It is not yet known whether standard care is more effective with or without acupressure wristbands in controlling acute and delayed nausea. PURPOSE: This randomized phase III trial is studying how well acupressure wristbands work with or without standard care in controlling nausea in young patients receiving highly emetogenic chemotherapy.

Key facts

Study ID

NCT01346267

Run by

University of South Florida

People needed

187

Starts

2011-05-01

Expected to finish

2016-05-01

Last updated by the study team

2021-08-18

Who can join

Age: 4 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 4 to 18 years of age, inclusive. The patient's cognitive ability must be considered by a parent or healthcare professional to be at least at a 4 year-old level.
• Newly diagnosed (i.e., not relapsed) with any malignancy.
• Patients are not required to be registered on a COG therapeutic trial.
• The patient's current chemotherapy treatment plan must include at least 1 course of
• cisplatin at ≥ 50 mg/m2/dose or
• ifosfamide plus etoposide or doxorubicin or
• cyclophosphamide plus an anthracycline.
• Patients may have previously received other chemotherapy.
• The patient's current treatment plan must include an anti-emetic regimen with either ondansetron or granisetron on a scheduled basis. Patients may also receive dexamethasone for antiemetic prophylaxis during the acute phase at the discretion of the treating physician. Patients ≥ 12 years old may also receive aprepitant in conjunction with dexamethasone for antiemetic prophylaxis at the discretion of the treating physician.
• Patients needing anti-emetic treatment for breakthrough nausea/vomiting may also receive anti-emetic agents on an as needed (PRN) basis.
• The patient (parent/guardian) must be English-speaking (i.e., able to read and speak in English) since the PeNAT has been validated only in English.
• All patients and/or their parents or legal guardians must sign a written informed consent (patient assent is also recommended when applicable according to each institution's policy).

You may not qualify if…

• Prior history of acupressure use.
• Scheduled use of antiemetic agents other than ondansetron, granisetron, dexamethasone or aprepitant. Patients may receive other antiemetic agents PRN for breakthrough nausea/vomiting but not on a scheduled basis

Where it is running

• Miller Children's Hospital — Long Beach, California, United States
• Childrens Hospital Los Angeles — Los Angeles, California, United States
• Connecticut Children's Medical Center — Hartford, Connecticut, United States
• A I duPont Hospital for Children — Wilmington, Delaware, United States
• Childrens National Medical Center — Washington D.C., District of Columbia, United States
• Children's Hospital of Southwest Florida at Lee Memorial — Fort Myers, Florida, United States
• Nemours Children's Clinic — Jacksonville, Florida, United States
• Palms West Hospital — Loxahatchee Groves, Florida, United States
• Nemours Children's Clinic - Orlando — Orlando, Florida, United States
• Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
• All Children's Hospital — St. Petersburg, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Kapiolani Medical for Women and Children — Honolulu, Hawaii, United States
• Ochsner Clinic Foundation New Orleans — New Orleans, Louisiana, United States
• Dana Farber Cancer Institute at Boston Children's Hospital — Boston, Massachusetts, United States
• Columbia University Medical Center — New York, New York, United States
• Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
• Mercy Children's Hospital — Toledo, Ohio, United States
• Randall Children's Hospital at Legacy Emanuel — Portland, Oregon, United States
• Driscoll Children's Hospital — Corpus Christi, Texas, United States
• CHRISTUS Santa Rosa Children's Hospital — San Antonio, Texas, United States
• Methodist Healthcare System of San Antonio — San Antonio, Texas, United States
• Scott & White Pediatrics — Temple, Texas, United States
• Primary Children's Medical Center — Salt Lake City, Utah, United States
• Hospital for Sick Children — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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