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| ID | Type | Description | Link |
|---|---|---|---|
| SCUSF-1202 | Other Identifier | SunCoast CCOP Research Base | |
| Previously COG-ACCL1032 | Other Identifier | Children's Oncology Group | |
| 5U10CA081920 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Real Acupressure Band | Procedure | Acupressure wristband |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Each day of Chemotherapy course. Maximum of 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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
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:
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Williams McLean, MD | Wake Forest University Health Sciences | Study Chair |
| Lee Dupuis, PhD | The Hospital for Sick Children | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miller Children's Hospital | Long Beach | California | 90801 | United States | ||
| Childrens Hospital Los Angeles |
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| ID | Title | Description |
|---|---|---|
| FG000 | Arm I- Real Acupressure Bands | 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. Real Acupressure Band: Acupressure wristband |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Placebo Acupressure Band |
| Procedure |
Sham wristband |
|
|
| 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 | Maximum of 14 days |
| Los Angeles |
| California |
| 90027 |
| United States |
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | United States |
| A I duPont Hospital for Children | Wilmington | Delaware | 19803 | United States |
| Childrens National Medical Center | Washington D.C. | District of Columbia | 20010 | United States |
| Children's Hospital of Southwest Florida at Lee Memorial | Fort Myers | Florida | 33901 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| Palms West Hospital | Loxahatchee Groves | Florida | 33470 | United States |
| Nemours Children's Clinic - Orlando | Orlando | Florida | 32806 | United States |
| Nemours Children's Clinic - Pensacola | Pensacola | Florida | 32504 | United States |
| All Children's Hospital | St. Petersburg | Florida | 33701 | United States |
| Tampa General Hospital | Tampa | Florida | 33606 | United States |
| Kapiolani Medical for Women and Children | Honolulu | Hawaii | 96813 | United States |
| Ochsner Clinic Foundation New Orleans | New Orleans | Louisiana | 70121 | United States |
| Dana Farber Cancer Institute at Boston Children's Hospital | Boston | Massachusetts | 02115 | United States |
| Columbia University Medical Center | New York | New York | 10032 | United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | 27157-1096 | United States |
| Mercy Children's Hospital | Toledo | Ohio | 43608 | United States |
| Randall Children's Hospital at Legacy Emanuel | Portland | Oregon | 97227 | United States |
| Driscoll Children's Hospital | Corpus Christi | Texas | 78411 | United States |
| CHRISTUS Santa Rosa Children's Hospital | San Antonio | Texas | 78229 | United States |
| Methodist Healthcare System of San Antonio | San Antonio | Texas | 78229 | United States |
| Scott & White Pediatrics | Temple | Texas | 76508 | United States |
| Primary Children's Medical Center | Salt Lake City | Utah | 84113-1100 | United States |
| Hospital for Sick Children | Toronto | Ontario | M5G 1X8 | Canada |
| FG001 | Arm II- Placebo Acupressure Bands | Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I. Placebo Acupressure Band: Sham wristband |
| COMPLETED |
|
| NOT COMPLETED |
|
93 participants were allocated to acupressure bands and 83 received the intervention. 94 participants were allocated to the placebo bands and 82 received the intervention.
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| ID | Title | Description |
|---|---|---|
| BG000 | Arm I- Real Acupressure Bands | 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. Real Acupressure Band: Acupressure wristband |
| BG001 | Arm II- Placebo Acupressure Bands | Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I. Placebo Acupressure Band: Sham wristband |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Diagnosis | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | The overall number of patients analyzed is 83 for Arm I and 82 for Arm II. Patients analyzed include the total number of patients that reported at least 1 PeNAT (Pediatric Nausea Assessment Tool) score on that day. The duration of the acute phase varied with chemotherapy regimen, according to study design. The number of patients receiving chemotherapy for longer than 3 days diminished each day, so days 4-7 were collapsed and considered a single day. | Posted | Count of Participants | Participants | Each day of Chemotherapy course. Maximum of 7 days |
|
|
| |||||||||||||||||||||||||||||
| Secondary | 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. | The overall number of patients analyzed is 83 for Arm I and 82 for Arm II. Patients analyzed include the total number of patients that reported at least 1 PeNAT (Pediatric Nausea Assessment Tool) score on that day. The duration of the acute phase varied with chemotherapy regimen, according to study design. The number of patients receiving chemotherapy for longer than 3 days diminished each day, so days 4-7 were collapsed and considered a single day. | Posted | Count of Participants | Participants | Maximum of 7 days after Acute Phase |
| |||||||||||||||||||||||||||||||
| Secondary | 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 | The overall number of participants analyzed is 83 participants in Arm I and 82 participants in Arm II. In the acute phase, 165 patients provided at least 1 PeNAT (Pediatric Nausea Assessment Tool) score. In the delayed phase, 144 patients contributed at least 1 PeNAT score. | Posted | Count of Participants | Participants | Maximum of 14 days |
|
First application of wrist bands through 8 days after administration of the last chemotherapy dose of the cisplatin-containing course.
Adverse events could spontaneously be communicated by the patient/family and/or elicited via the Final Questionnaire.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Arm I- Real Acupressure Bands | 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. Real Acupressure Band: Acupressure wristband | 0 | 83 | 0 | 83 | 0 | 83 |
| EG001 | Arm II- Placebo Acupressure Bands | Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I. Placebo Acupressure Band: Sham wristband | 0 | 82 | 0 | 82 | 0 | 82 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas W. McLean, MD | Wake Forest University School of Medicine | 336-716-4085 | tmclean@wfubmc.edu |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D014839 | Vomiting |
| D009325 | Nausea |
| D009837 | Oligodendroglioma |
| D001254 | Astrocytoma |
| D016545 | Choroid Plexus Neoplasms |
| D008579 | Meningioma |
| ID | Term |
|---|---|
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009422 | Nervous System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D002551 | Cerebral Ventricle Neoplasms |
| D001932 | Brain Neoplasms |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009383 | Neoplasms, Vascular Tissue |
| D008577 | Meningeal Neoplasms |
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| Male |
|
| Hodgkin Lymphoma |
|
| Ewing Sarcoma |
|
| Other |
|
| Mild Nausea |
|
| Moderate Nausea |
|
| Severe Nausea |
|
| Day 2 |
|
|
| Day 3 |
|
|
| Days 4-7 |
|
|
| OG001 | Arm II- Placebo Acupressure Bands | Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I. Placebo Acupressure Band: Sham wristband |
|
|
| OG001 | Arm II- Placebo Acupressure Bands | Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I. Placebo Acupressure Band: Sham wristband |
|
|
| Mild Nausea |
|
| Moderate Nausea |
|
| Severe Nausea |
|
| Mild Nausea |
|
| Moderate Nausea |
|
| Severe Nausea |
|
| Mild Nausea |
|
| Moderate Nausea |
|
| Severe Nausea |
|
| Partial CIV Control |
|
| Failed CIV Control |
|