Acupressure in Controlling Nausea in Young Patients 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:

- 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