Central Nervous System Tumor, PediatricSCUSF1202NCT01346267
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
A study testing Real Acupressure Band in people with Central Nervous System Tumor, Pediatric and Chemotherapy-induced Nausea and Vomiting, run by University of South Florida at 25 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 18 years
- Conditions the study is for
- Central Nervous System Tumor, Pediatric, Chemotherapy-induced Nausea and Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific
- What is being tested?
- Real Acupressure Band
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 187 participants
- Where
- 25 sitesin 2 countries
- Study dates
- May 2011to May 2016
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Show all 12Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
25 sites in 2 countries.
25 sites in 2 countries
United States24 sites
Dana Farber Cancer Institute at Boston Children's Hospital
Boston, Massachusetts, 02115
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Children's Hospital of Southwest Florida at Lee Memorial
Fort Myers, Florida, 33901
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Kapiolani Medical for Women and Children
Honolulu, Hawaii, 96813
Nemours Children's Clinic
Jacksonville, Florida, 32207
Miller Children's Hospital
Long Beach, California, 90801
Childrens Hospital Los Angeles
Los Angeles, California, 90027
Palms West Hospital
Loxahatchee Groves, Florida, 33470
Ochsner Clinic Foundation New Orleans
New Orleans, Louisiana, 70121
Columbia University Medical Center
New York, New York, 10032
Nemours Children's Clinic - Orlando
Orlando, Florida, 32806
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, 97227
Primary Children's Medical Center
Salt Lake City, Utah, 84113-1100
CHRISTUS Santa Rosa Children's Hospital
San Antonio, Texas, 78229
Methodist Healthcare System of San Antonio
San Antonio, Texas, 78229
All Children's Hospital
St. Petersburg, Florida, 33701
Tampa General Hospital
Tampa, Florida, 33606
Scott & White Pediatrics
Temple, Texas, 76508
Mercy Children's Hospital
Toledo, Ohio, 43608
Childrens National Medical Center
Washington D.C., District of Columbia, 20010
A I duPont Hospital for Children
Wilmington, Delaware, 19803
Wake Forest University Health Sciences
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy
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.
Read the 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.
- Conditions
- Central Nervous System Tumor, Pediatric, Chemotherapy-induced Nausea and Vomiting, Unspecified Childhood Solid Tumor, Protocol Specific
- Being tested
- Real Acupressure Band, Placebo Acupressure Band
- 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
- Medical subject headings
- Central Nervous System Neoplasms, Vomiting, Nausea, Oligodendroglioma, Astrocytoma, Choroid Plexus Neoplasms, Meningioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Real Acupressure BandProcedure or surgery
Acupressure wristband
Placebo Acupressure BandProcedure or surgery
Also called sham intervention
Sham wristband
| Study group | Role | What they receive |
|---|---|---|
| Arm I- Real Acupressure bands | Experimental | 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. Receives: Procedure: Real Acupressure Band |
| Arm II- Placebo Acupressure Bands | Sham comparator | Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I. Receives: Procedure: Placebo Acupressure Band |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy
CIN = Chemotherapy-Induced Nausea. The acute phase began with administration of the first chemotherapy dose of a chemotherapy block and continued until 24 hours after administration of the last chemotherapy dose of the block. Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose. Nausea severity during the acute phase of chemotherapy is defined as the maximum PeNAT (Pediatric Nausea Assessment Tool) score observed during each 24 hour period. The possible scores for the pediatric nausea assessment tool are no nausea, mild nausea, moderate nausea, severe nausea. Only patients who contributed at least 1 PeNAT score during the acute phase were included. The duration of the acute phase varied with chemotherapy regimen, according to study design.
Measured: Each day of Chemotherapy course. Maximum of 7 days
Secondary outcomes (2)
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy
CIN = Chemotherapy-Induced Nausea. The delayed phase began at the end of the acute phase and continued until the first chemotherapy dose of the next chemotherapy block. Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first. Nausea severity is defined as the maximum PeNAT (Pediatric Nausea Assessment Tool) score observed during each 24 hour period. The possible scores for the pediatric nausea assessment tool are no nausea, mild nausea, moderate nausea, severe nausea. Only patients who contributed at least 1 PeNAT score during the delayed phase were included.
Measured: Maximum of 7 days after Acute Phase
Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy
CIV = Chemotherapy-Induced Vomiting. 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. A breakthrough antiemetic agent is defined as a medication that is administered or taken in order to relieve or treat (rather than prevent) nausea or vomiting. An antiemetic agent that is prescribed and/or administered on an "as needed" basis is considered to be a breakthrough antiemetic. Complete CIV Control during the acute and delayed phases is defined as no emetic episodes and no breakthrough anti-emetic agents administered during the phase of interest. Partial CIV Control is defined as 1 or 2 emetic episodes in any 24 ho
Measured: Maximum of 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 May 2011 (estimated)
- Study startMay 2011
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Central Nervous System Tumor, PediatricStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 187 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Thomas Williams McLean, MD, Study chair, Wake Forest University Health SciencesLee Dupuis, PhD, Study chair, The Hospital for Sick Children
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01346267
- Sponsor's protocol ID
- SCUSF 1202
- Other IDs
- SCUSF-1202, Previously COG-ACCL1032, 5U10CA081920
- Acronym
- SCUSF1202
- Status last verified
- Oct 2017
- First submitted
- 29 Apr 2011
- Last updated
- 18 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes