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SCUSF 1202 A Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy (previously ACCL1032)

Study Chair:
Thomas W. McLean, MD
Lee Dupuis, MscPhm
Status:
Approved by NCI
Activation Date: 8/30/2012
NCT01346267

Study Objectives

The primary objective of this study is to compare the control of chemotherapy-induced nausea (CIN) in the acute phase provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin greater than or equal to 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

Secondary objectives of this study are to:

  • To compare the control of CIN in the delayed phase provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin greater than or equal to 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.
  • To compare the control of chemotherapy-induced vomiting and retching (CIV) in the acute and delayed phases provided by a 5-HT3 antagonist combined with acupressure versus placebo acupressure in children 4 to 18 years of age being treated with chemotherapy including cisplatin greater than or equal to 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

Subject Selection

Inclusion Criteria:

  • 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 greater than or equal to 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 and older 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).

  • Signed HIPAA compliant research authorization (or equivalent for international sites) to release Personal Health Information to the SunCoast CCOP Research Base must be obtained prior to registration.
Exclusion Criteria:
  • 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.

Link to Abstract

Please note, this information may change if the protocol is amended. Please refer to the current protocol for the most accurate information such as a complete list of the eligibility requirements.

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