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Trial record 2 of 3 for:    "Germinoma" | "Gastrointestinal Agents"

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

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ClinicalTrials.gov Identifier: NCT01346267
Recruitment Status : Completed
First Posted : May 2, 2011
Last Update Posted : October 27, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of South Florida

Tracking Information
First Submitted Date  ICMJE April 29, 2011
First Posted Date  ICMJE May 2, 2011
Last Update Posted Date October 27, 2017
Study Start Date  ICMJE May 2011
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
Control of CIN during acute phase of chemotherapy [ Time Frame: Each day of Chemotherapy course. Maximum of 7 days ]
Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose
Original Primary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
Control of CIN during acute phase of chemotherapy
Change History Complete list of historical versions of study NCT01346267 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 20, 2013)
  • Control of CIN during delayed phase of chemotherapy [ Time Frame: Maximum of 7 days after Acute Phase ]
    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 ]
    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.
Original Secondary Outcome Measures  ICMJE
 (submitted: April 29, 2011)
  • Control of CIN during delayed phase of chemotherapy
  • Comparison of CIN during acute and delayed phase of chemotherapy
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
Official Title  ICMJE Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy
Brief 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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Condition  ICMJE
  • Central Nervous System Tumor, Pediatric
  • Chemotherapy-induced Nausea and Vomiting
  • Unspecified Childhood Solid Tumor, Protocol Specific
Intervention  ICMJE
  • Procedure: Real Acupressure Band
    Acupressure wristband
  • Procedure: Placebo Acupressure Band
    Sham wristband
    Other Name: sham intervention
Study Arms  ICMJE
  • 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.
    Intervention: Procedure: Real Acupressure Band
  • 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.
    Intervention: Procedure: Placebo Acupressure Band
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 9, 2016)
187
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2011)
400
Actual Study Completion Date  ICMJE May 2016
Actual Primary Completion Date May 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 4 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries Australia
 
Administrative Information
NCT Number  ICMJE NCT01346267
Other Study ID Numbers  ICMJE SCUSF 1202
SCUSF-1202 ( Other Identifier: SunCoast CCOP Research Base )
Previously COG-ACCL1032 ( Other Identifier: Children's Oncology Group )
5U10CA081920 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University of South Florida
Study Sponsor  ICMJE University of South Florida
Collaborators  ICMJE National Cancer Institute (NCI)
Investigators  ICMJE
Study Chair: Thomas Williams McLean, MD Wake Forest University Health Sciences
Study Chair: Lee Dupuis, PhD The Hospital for Sick Children
PRS Account University of South Florida
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP