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Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy


Phase 3
4 Years
18 Years
Open (Enrolling)
Both
Central Nervous System Tumor, Pediatric, Chemotherapy-induced Nausea and Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific

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Trial Information

Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy


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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Outcome Measure:

Control of CIN during acute phase of chemotherapy

Outcome Description:

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

Outcome Time Frame:

Each day of Chemotherapy course. Maximum of 7 days

Safety Issue:

No

Principal Investigator

Thomas Williams McLean, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Comprehensive Cancer Center of Wake Forest University

Authority:

United States: Data and Safety Monitoring Board

Study ID:

SCUSF 1202

NCT ID:

NCT01346267

Start Date:

May 2011

Completion Date:

Related Keywords:

  • Central Nervous System Tumor, Pediatric
  • Chemotherapy-Induced Nausea and Vomiting
  • Unspecified Childhood Solid Tumor, Protocol Specific
  • 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
  • Nausea
  • Nervous System Neoplasms
  • Vomiting
  • Central Nervous System Neoplasms

Name

Location
Nemours Children's Clinic Jacksonville, Florida  32207
All Children's Hospital St. Petersburg, Florida  33701
Lee Cancer Care of Lee Memorial Health System Fort Myers, Florida  33901
Nemours Children's Clinic - Orlando Orlando, Florida  32806
Primary Children's Medical Center Salt Lake City, Utah  84113-1100
Childrens Hospital Los Angeles Los Angeles, California  90027
Connecticut Children's Medical Center Hartford, Connecticut  06106
Nemours Children's Clinic - Pensacola Pensacola, Florida  32504
Mercy Children's Hospital Toledo, Ohio  43608
Wake Forest University Health Sciences Winston-Salem, North Carolina  27157
Columbia University Medical Center New York, New York  10032
Miller Children's Hospital Long Beach, California  90806
Kapiolani Medical for Women and Children Honolulu, Hawaii  96813
Dana Farber Cancer Institute at Boston Children's Hospital Boston, Massachusetts  02115
Randall Children's Hospital at Legacy Emanuel Portland, Oregon  97227