Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy

Unspecified Childhood Solid Tumor, Protocol Specific Clinical Trial

— SCUSF1202  

Official title:

Randomized Controlled Trial of Acupressure to Control Chemotherapy-Induced Nausea (CIN) in Children Receiving Highly Emetogenic Chemotherapy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01346267
• Other study ID #: SCUSF 1202
• Secondary ID: SCUSF-1202Previo
• Status: Completed
• Phase: N/A
• Start date: May 2011
• Est. completion date: May 2016

Study information

• Verified date: October 2017
• Source: University of South Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 187
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 4 Years to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumor, Pediatric
• Chemotherapy-induced Nausea and Vomiting
• Nausea
• Neoplasms
• Nervous System Neoplasms
• Unspecified Childhood Solid Tumor, Protocol Specific
• Vomiting

Intervention

Procedure:
• Real Acupressure Band
Acupressure wristband
• Placebo Acupressure Band
Sham wristband

Locations

Country	Name	City	State
Canada	Hospital for Sick Children	Toronto	Ontario
United States	Dana Farber Cancer Institute at Boston Children's Hospital	Boston	Massachusetts
United States	Driscoll Children's Hospital	Corpus Christi	Texas
United States	Children's Hospital of Southwest Florida at Lee Memorial	Fort Myers	Florida
United States	Connecticut Children's Medical Center	Hartford	Connecticut
United States	Kapiolani Medical for Women and Children	Honolulu	Hawaii
United States	Nemours Children's Clinic	Jacksonville	Florida
United States	Miller Children's Hospital	Long Beach	California
United States	Childrens Hospital Los Angeles	Los Angeles	California
United States	Palms West Hospital	Loxahatchee Groves	Florida
United States	Ochsner Clinic Foundation New Orleans	New Orleans	Louisiana
United States	Columbia University Medical Center	New York	New York
United States	Nemours Children's Clinic - Orlando	Orlando	Florida
United States	Nemours Children's Clinic - Pensacola	Pensacola	Florida
United States	Randall Children's Hospital at Legacy Emanuel	Portland	Oregon
United States	All Children's Hospital	Saint Petersburg	Florida
United States	Primary Children's Medical Center	Salt Lake City	Utah
United States	CHRISTUS Santa Rosa Children's Hospital	San Antonio	Texas
United States	Methodist Healthcare System of San Antonio	San Antonio	Texas
United States	Tampa General Hospital	Tampa	Florida
United States	Scott & White Pediatrics	Temple	Texas
United States	Mercy Children's Hospital	Toledo	Ohio
United States	Childrens National Medical Center	Washington	District of Columbia
United States	A I duPont Hospital for Children	Wilmington	Delaware
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Cancer Institute (NCI)

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	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	Maximum of 14 days