Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy

Not Applicable

Completed

• Conditions: Central Nervous System Tumor, Pediatric; Unspecified Childhood Solid Tumor, Protocol Specific; Chemotherapy-induced Nausea and Vomiting
• Interventions: Procedure: Placebo Acupressure Band; Procedure: Real Acupressure Band

• Registration Number: NCT01346267
• Lead Sponsor: University of South Florida

Brief 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.

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.

Study Timeline

• Study First Submitted: 2011-04-29
• Study First Submitted QC: 2011-04-29
• Study Start: 2011-05
• Study First Posted: 2011-05-02
• Primary Completion: 2016-05
• Study Completion: 2016-05
• Status Verified: 2017-10
• Results First Submitted: 2021-06-03
• Results First Submitted QC: 2021-06-03
• Results First Posted: 2021-06-25
• Last Update Submitted: 2021-07-19
• Last Update Posted: 2021-08-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 187

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm II- Placebo Acupressure Bands	Placebo Acupressure Band	Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.
Arm I- Real Acupressure bands	Real Acupressure Band	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.

Primary Outcome Measures

Name	Time	Method
Efficacy of Treatment on CIN During Acute Phase of Chemotherapy	Each day of Chemotherapy course. Maximum of 7 days	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.

Secondary Outcome Measures

Name	Time	Method
Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy	Maximum of 7 days after Acute Phase	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.
Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy	Maximum of 14 days	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

Trial Locations

Locations (25)

Childrens Hospital Los Angeles; 🇺🇸 Los Angeles, California, United States

Nemours Children's Clinic; 🇺🇸 Jacksonville, Florida, United States

Childrens National Medical Center; 🇺🇸 Washington, District of Columbia, United States

Columbia University Medical Center; 🇺🇸 New York, New York, United States

Children's Hospital of Southwest Florida at Lee Memorial; 🇺🇸 Fort Myers, Florida, United States

Dana Farber Cancer Institute at Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

CHRISTUS Santa Rosa Children's Hospital; 🇺🇸 San Antonio, Texas, United States

Nemours Children's Clinic - Orlando; 🇺🇸 Orlando, Florida, United States

Kapiolani Medical for Women and Children; 🇺🇸 Honolulu, Hawaii, United States

Nemours Children's Clinic - Pensacola; 🇺🇸 Pensacola, Florida, United States

Ochsner Clinic Foundation New Orleans; 🇺🇸 New Orleans, Louisiana, United States

Randall Children's Hospital at Legacy Emanuel; 🇺🇸 Portland, Oregon, United States

Mercy Children's Hospital; 🇺🇸 Toledo, Ohio, United States

Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada

All Children's Hospital; 🇺🇸 Saint Petersburg, Florida, United States

Methodist Healthcare System of San Antonio; 🇺🇸 San Antonio, Texas, United States

Miller Children's Hospital; 🇺🇸 Long Beach, California, United States

A I duPont Hospital for Children; 🇺🇸 Wilmington, Delaware, United States

Connecticut Children's Medical Center; 🇺🇸 Hartford, Connecticut, United States

Palms West Hospital; 🇺🇸 Loxahatchee Groves, Florida, United States

Scott & White Pediatrics; 🇺🇸 Temple, Texas, United States

Driscoll Children's Hospital; 🇺🇸 Corpus Christi, Texas, United States

Primary Children's Medical Center; 🇺🇸 Salt Lake City, Utah, United States

Wake Forest University Health Sciences; 🇺🇸 Winston-Salem, North Carolina, United States