Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy (SCUSF1202)
This study is currently recruiting participants.
Verified May 2012 by University of South Florida
Sponsor:
University of South Florida
Collaborator:
Information provided by (Responsible Party):
University of South Florida
ClinicalTrials.gov Identifier:
NCT01346267
First received: April 29, 2011
Last updated: May 20, 2013
Last verified: May 2012
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Brain and Central Nervous System Tumors Nausea and Vomiting Unspecified Childhood Solid Tumor, Protocol Specific |
Procedure: Real Acupressure Band Procedure: Placebo Acupressure Band |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Subject) Primary Purpose: Supportive Care |
| Official Title: | Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy |
Resource links provided by NLM:
Further study details as provided by University of South Florida:
Primary Outcome Measures:
- Control of CIN during acute phase of chemotherapy [ Time Frame: Each day of Chemotherapy course. Maximum of 7 days ] [ Designated as safety issue: No ]Acute Phase - bands will be worn on each day of the chemotherapy course and for 24 hours after the last chemotherapy dose
Secondary Outcome Measures:
- Control of CIN during delayed phase of chemotherapy [ Time Frame: Maximum of 7 days after Acute Phase ] [ Designated as safety issue: No ]Delayed Phase - Bands will continue to be worn for a maximum of 7 days or until the next chemotherapy cycle starts, whichever comes first.
- Comparison of CIN during acute and delayed phase of chemotherapy [ Time Frame: Maximum of 14 days ] [ Designated as safety issue: No ]
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.
| Estimated Enrollment: | 400 |
| Study Start Date: | May 2011 |
| Estimated Primary Completion Date: | December 2016 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Procedure: Real Acupressure Band
Acupressure wristband
|
|
Sham Comparator: 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.
|
Procedure: Placebo Acupressure Band
Sham wristband
Other Name: sham intervention
|
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.
Eligibility| Ages Eligible for Study: | 4 Years to 18 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01346267
Locations
| United States, California | |
| Miller Children's Hospital | Recruiting |
| Long Beach, California, United States, 90801 | |
| Contact: Amanda M. Termuhlen 562-933-8605 | |
| Principal Investigator: Amanda Termuhlen | |
| Childrens Hospital Los Angeles | Recruiting |
| Los Angeles, California, United States, 90027 | |
| Contact: Keley Haley, RN 323-361-2480 | |
| Principal Investigator: Kelley Haley | |
| United States, Connecticut | |
| Connecticut Children's Medical Center | Recruiting |
| Hartford, Connecticut, United States, 06106 | |
| Contact: Clinical Trials Office - Connecticut Children's Medical Center 860-545-9967 | |
| Principal Investigator: Michael Isakoff, MD | |
| United States, Florida | |
| Lee Cancer Care of Lee Memorial Health System | Recruiting |
| Fort Myers, Florida, United States, 33901 | |
| Contact: Molly Arnstrom 239-343-6959 | |
| Principal Investigator: Emad Salman, MD | |
| Nemours Children's Clinic | Recruiting |
| Jacksonville, Florida, United States, 32207 | |
| Contact: Eric S. Sandler 904-697-3793 | |
| Principal Investigator: Eric Sandler, MD | |
| Nemours Children's Clinic - Orlando | Recruiting |
| Orlando, Florida, United States, 32806 | |
| Contact: Kristen Gibbs 407-650-7230 | |
| Principal Investigator: Ramamoorthy Nagasubramanian, MD | |
| Nemours Children's Clinic - Pensacola | Recruiting |
| Pensacola, Florida, United States, 32504 | |
| Contact: Jeffrey H. Schwartz 850-505-4790 | |
| Principal Investigator: Jeffrey Schwartz, MD | |
| All Children's Hospital | Recruiting |
| Saint Petersburg, Florida, United States, 33701 | |
| Contact: Gregory A. Hale 727-767-4176 | |
| Principal Investigator: Gregory Hale, MD | |
| United States, Hawaii | |
| Kapiolani Medical for Women and Children | Recruiting |
| Honolulu, Hawaii, United States, 96813 | |
| Contact: Emele Chang 808-586-2979 | |
| Principal Investigator: Robert Wilkinson, MD | |
| United States, Massachusetts | |
| Dana Farber Cancer Institute at Boston Children's Hospital | Recruiting |
| Boston, Massachusetts, United States, 02115 | |
| Contact: Michelle Ellis 617-632-4595 | |
| Principal Investigator: Nicole Ullrich, MD PhD | |
| United States, New York | |
| Columbia University Medical Center | Recruiting |
| New York City, New York, United States, 10032 | |
| Contact: Margie Negron 212-305-8630 | |
| Principal Investigator: Stephen Sands, Psy.D. | |
| United States, North Carolina | |
| Wake Forest University Health Sciences | Recruiting |
| Winston-Salem, North Carolina, United States, 27157-1096 | |
| Contact: Graham Keyes 336-716-9027 | |
| Principal Investigator: Thomas McLean, MD | |
| United States, Ohio | |
| Mercy Children's Hospital | Recruiting |
| Toledo, Ohio, United States, 43608 | |
| Contact: Trish Ahrens 419-251-8075 | |
| Principal Investigator: Rama Jasty, MD | |
| United States, Oregon | |
| Randall Children's Hospital at Legacy Emanuel | Recruiting |
| Portland, Oregon, United States, 97227 | |
| Contact: Martha Rashko, CCRP 503-276-9376 | |
| Principal Investigator: Janice F Olson, MD | |
| United States, Utah | |
| Primary Children's Medical Center | Recruiting |
| Salt Lake City, Utah, United States, 84113-1100 | |
| Contact: Phillip E. Barnette 801-662-4700 | |
| Principal Investigator: Phillip Barnette, MD | |
| Canada, Ontario | |
| Hospital for Sick Children | Recruiting |
| Toronto, Ontario, Canada, M5G 1X8 | |
| Contact: Entela Zaffino 416-813-5055 | |
| Principal Investigator: Lillian Sung | |
| Principal Investigator: Lee Dupuis | |
Sponsors and Collaborators
University of South Florida
Investigators
| Study Chair: | Thomas Williams McLean, MD | Comprehensive Cancer Center of Wake Forest University |
| Study Chair: | Lee Dupuis, MScPhm | The Hospital for Sick Children |
More Information
Additional Information:
No publications provided
| Responsible Party: | University of South Florida |
| ClinicalTrials.gov Identifier: | NCT01346267 History of Changes |
| Other Study ID Numbers: | SCUSF 1202, SCUSF-1202, COG-ACCL1032 |
| Study First Received: | April 29, 2011 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Data and Safety Monitoring Board United States: Federal Government United States: Institutional Review Board |
Keywords provided by University of South Florida:
|
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 untreated childhood supratentorial primitive neuroectodermal tumor childhood medulloepithelioma childhood infratentorial ependymoma newly diagnosed childhood ependymoma |
Additional relevant MeSH terms:
|
Nausea Vomiting Nervous System Neoplasms Central Nervous System Neoplasms Signs and Symptoms, Digestive Signs and Symptoms Neoplasms by Site Neoplasms Nervous System Diseases |
Emetics Physiological Effects of Drugs Pharmacologic Actions Autonomic Agents Peripheral Nervous System Agents Central Nervous System Agents Therapeutic Uses Gastrointestinal Agents |
ClinicalTrials.gov processed this record on June 18, 2013