Clinical trial NCT01346267: Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
Official title: Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Nervous System Tumor, Pediatric
Chemotherapy-induced Nausea and Vomiting
Unspecified Childhood Solid Tumor, Protocol Specific
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
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2011-05-02
Enrollment: 187
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility 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

Primary outcomes:
measure: Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
timeFrame: Each day of Chemotherapy course. Maximum of 7 days
Secondary outcomes:
measure: Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
timeFrame: Maximum of 7 days after Acute Phase
measure: Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy
timeFrame: Maximum of 14 days
Other outcomes:
Locations:
city: Long Beach
country: United States
facility: Miller Children's Hospital
state: California
city: Los Angeles
country: United States
facility: Childrens Hospital Los Angeles
state: California
city: Hartford
country: United States
facility: Connecticut Children's Medical Center
state: Connecticut
city: Wilmington
country: United States
facility: A I duPont Hospital for Children
state: Delaware
city: Washington
country: United States
facility: Childrens National Medical Center
state: District of Columbia
city: Fort Myers
country: United States
facility: Children's Hospital of Southwest Florida at Lee Memorial
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Clinic
state: Florida
city: Loxahatchee Groves
country: United States
facility: Palms West Hospital
state: Florida
city: Orlando
country: United States
facility: Nemours Children's Clinic - Orlando
state: Florida
city: Pensacola
country: United States
facility: Nemours Children's Clinic - Pensacola
state: Florida
city: Saint Petersburg
country: United States
facility: All Children's Hospital
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Honolulu
country: United States
facility: Kapiolani Medical for Women and Children
state: Hawaii
city: New Orleans
country: United States
facility: Ochsner Clinic Foundation New Orleans
state: Louisiana
city: Boston
country: United States
facility: Dana Farber Cancer Institute at Boston Children's Hospital
state: Massachusetts
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Toledo
country: United States
facility: Mercy Children's Hospital
state: Ohio
city: Portland
country: United States
facility: Randall Children's Hospital at Legacy Emanuel
state: Oregon
city: Corpus Christi
country: United States
facility: Driscoll Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: CHRISTUS Santa Rosa Children's Hospital
state: Texas
city: San Antonio
country: United States
facility: Methodist Healthcare System of San Antonio
state: Texas
city: Temple
country: United States
facility: Scott & White Pediatrics
state: Texas
city: Salt Lake City
country: United States
facility: Primary Children's Medical Center
state: Utah
city: Toronto
country: Canada
facility: Hospital for Sick Children
state: Ontario
Study officials:
affiliation: Wake Forest University Health Sciences
name: Thomas Williams McLean, MD
role: STUDY_CHAIR
affiliation: The Hospital for Sick Children
name: Lee Dupuis, PhD
role: STUDY_CHAIR
References: