Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy (SCUSF1202)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by University of South Florida
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01346267
First received: April 29, 2011
Last updated: July 3, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Central Nervous System Tumor, Pediatric
Chemotherapy-induced Nausea and Vomiting
Unspecified Childhood Solid Tumor, Protocol Specific
Procedure: Real Acupressure Band
Procedure: Placebo Acupressure Band
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy

Resource links provided by NLM:


Further study details as provided by University of South Florida:

Primary Outcome Measures:
  • Control of CIN during acute phase of chemotherapy [ Time Frame: Each day of Chemotherapy course. Maximum of 7 days ] [ Designated as safety issue: No ]
    Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose


Secondary Outcome Measures:
  • Control of CIN during delayed phase of chemotherapy [ Time Frame: Maximum of 7 days after Acute Phase ] [ Designated as safety issue: No ]
    Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first.

  • Comparison of CIN during acute and delayed phase of chemotherapy [ Time Frame: Maximum of 14 days ] [ Designated as safety issue: No ]

    Total Duration of Study includes both acute and delayed phases.

    Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose

    Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first.



Estimated Enrollment: 240
Study Start Date: May 2011
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I- Real Acupressure bands
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.
Procedure: Real Acupressure Band
Acupressure wristband
Sham Comparator: Arm II- Placebo Acupressure Bands
Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.
Procedure: Placebo Acupressure Band
Sham wristband
Other Name: sham intervention

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.

  Eligibility

Ages Eligible for Study:   4 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ≥ 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).

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01346267

  Show 23 Study Locations
Sponsors and Collaborators
University of South Florida
Investigators
Study Chair: Thomas Williams McLean, MD Comprehensive Cancer Center of Wake Forest University
Study Chair: Lee Dupuis, MScPhm The Hospital for Sick Children
  More Information

Additional Information:
No publications provided

Responsible Party: University of South Florida
ClinicalTrials.gov Identifier: NCT01346267     History of Changes
Other Study ID Numbers: SCUSF 1202, SCUSF-1202, Previously COG-ACCL1032, 5U10CA081920
Study First Received: April 29, 2011
Last Updated: July 3, 2014
Health Authority: United States: Data and Safety Monitoring Board
United States: Federal Government
United States: Institutional Review Board

Keywords provided by University of South Florida:
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

Additional relevant MeSH terms:
Nausea
Nervous System Neoplasms
Vomiting
Central Nervous System Neoplasms
Signs and Symptoms, Digestive
Signs and Symptoms
Neoplasms by Site
Neoplasms
Nervous System Diseases
Emetics
Physiological Effects of Drugs
Pharmacologic Actions
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Gastrointestinal Agents

ClinicalTrials.gov processed this record on August 21, 2014