Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
Condition: Central Nervous System Tumor, Pediatric; Chemotherapy-induced Nausea and Vomiting; Unspecified Childhood Solid Tumor, Protocol Specific
MeSH terms: Neoplasms; Nervous System Neoplasms; Central Nervous System Neoplasms; Nausea; Vomiting
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      OBJECTIVES:

      Primary

        -  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 ≥ 50 mg/m2/dose,
           ifosfamide plus etoposide/doxorubicin, or cyclophosphamide plus an anthracycline.

      Secondary

        -  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 ≥ 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 ≥ 50 mg/m2/dose, ifosfamide plus etoposide/doxorubicin, or
           cyclophosphamide plus an anthracycline.

      OUTLINE: This is a multicenter study. Patients are stratified according chemotherapy regimen
      and anti-emetic Regimen 5-HT3 agonists (ondansetron or granisetron.) Patients are randomized
      to 1 of 2 treatment arms.

        -  Arm I: Patients wear Sea-Band acupressure wristbands on each wrist beginning
           approximately 30 minutes prior to the first cisplatin-containing chemotherapy course and
           continually for 24 hours after the last chemotherapy dose (acute phase), and for a
           maximum of 7 days or until the next chemotherapy course starts (delayed phase). Patients
           are allowed to take bands off intermittently (up to 4 times a day, for no more than 15
           minutes each time) to relieve pressure or to bathe. Patients also receive standard of
           care anti-emetic prophylaxis comprising granisetron, ondansetron, or dexamethasone
           during chemotherapy according to institutional or physician preference.

        -  Arm II: Patients wear placebo wristbands on each wrist and receive standard of care
           anti-emetic prophylaxis during chemotherapy as patients in arm I.

      Patients, parents, or guardians are instructed to complete an impatient and an outpatient
      diaries on nausea severity and the time of each emetic episode. Patients, parents, or
      guardians also complete a questionnaire about acupressure at the end of the study.
    

Intervention name(s): Real Acupressure Band; Placebo Acupressure Band
Intervention type(s): Procedure; Procedure
Intervention description(s): Acupressure wristband; Sham wristband
Other intervention name(s): sham intervention
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Participant)
Primary purpose: Supportive Care
Keywords: nausea and vomiting; unspecified childhood solid tumor; childhood central nervous system embryonal tumor; childhood central nervous system germ cell tumor; childhood central nervous system germinoma; childhood central nervous system mixed germ cell tumor; childhood central nervous system teratoma; childhood central nervous system yolk sac tumor; childhood mixed glioma; childhood oligodendroglioma; untreated childhood brain stem glioma; untreated childhood visual pathway and hypothalamic glioma; untreated childhood visual pathway glioma; childhood high-grade cerebellar astrocytoma; childhood high-grade cerebral astrocytoma; childhood low-grade cerebellar astrocytoma; childhood low-grade cerebral astrocytoma; untreated childhood cerebellar astrocytoma; untreated childhood cerebral astrocytoma; untreated childhood subependymal giant cell astrocytoma; childhood ependymoblastoma; untreated childhood medulloblastoma; untreated childhood pineoblastoma; childhood choroid plexus tumor; childhood craniopharyngioma; childhood supratentorial ependymoma; childhood supratentorial primitive neuroectodermal tumor; childhood medulloepithelioma; childhood infratentorial ependymoma; newly diagnosed childhood ependymoma; childhood meningioma