Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy
- 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
- 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.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care
Control of CIN during acute phase of chemotherapy
Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose
Each day of Chemotherapy course. Maximum of 7 days
Thomas Williams McLean, MD
Comprehensive Cancer Center of Wake Forest University
United States: Data and Safety Monitoring Board
|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|