Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy

NCT01346267 | Completed Results DMC

• 4 other identifiers: SCUSF 1202SCUSF-1202Previously COG-ACCL10325U10CA081920
• Study Type: interventional
• Target: 187
• Locations: 2 countries
• Sites: 25

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.

Conditions

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

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; childhood ependymoblastoma; untreated childhood medulloblastoma; untreated childhood pineoblastoma; childhood choroid plexus tumor; childhood craniopharyngioma; childhood supratentorial ependymoma; childhood supratentorial primitive neuroectodermal tumor; childhood medulloepithelioma; childhood infratentorial ependymoma; newly diagnosed childhood ependymoma; childhood meningioma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy

  Maximum of 7 days after Acute Phase

• Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy

  Maximum of 14 days

Study Arms (2)

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.

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.

Procedure: Placebo Acupressure Band

Interventions

Real Acupressure Band PROCEDURE

Acupressure wristband

Arm I- Real Acupressure bands

Placebo Acupressure Band PROCEDURE

Sham wristband

Also known as: sham intervention

Arm II- Placebo Acupressure Bands

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University of South Florida: lead
• National Cancer Institute (NCI): collaborator

Study Sites (25)

Miller Children's Hospital

Long Beach, California, 90801, United States

Location

Childrens Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

A I duPont Hospital for Children

Wilmington, Delaware, 19803, United States

Location

Childrens National Medical Center

Washington D.C., District of Columbia, 20010, United States

Location

Children's Hospital of Southwest Florida at Lee Memorial

Fort Myers, Florida, 33901, United States

Location

Nemours Children's Clinic

Jacksonville, Florida, 32207, United States

Location

Palms West Hospital

Loxahatchee Groves, Florida, 33470, United States

Location

Nemours Children's Clinic - Orlando

Orlando, Florida, 32806, United States

Location

Nemours Children's Clinic - Pensacola

Pensacola, Florida, 32504, United States

Location

All Children's Hospital

St. Petersburg, Florida, 33701, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Kapiolani Medical for Women and Children

Honolulu, Hawaii, 96813, United States

Location

Ochsner Clinic Foundation New Orleans

New Orleans, Louisiana, 70121, United States

Location

Dana Farber Cancer Institute at Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Columbia University Medical Center

New York, New York, 10032, United States

Location

Wake Forest University Health Sciences

Winston-Salem, North Carolina, 27157-1096, United States

Location

Mercy Children's Hospital

Toledo, Ohio, 43608, United States

Location

Randall Children's Hospital at Legacy Emanuel

Portland, Oregon, 97227, United States

Location

Driscoll Children's Hospital

Corpus Christi, Texas, 78411, United States

Location

CHRISTUS Santa Rosa Children's Hospital

San Antonio, Texas, 78229, United States

Location

Methodist Healthcare System of San Antonio

San Antonio, Texas, 78229, United States

Location

Scott & White Pediatrics

Temple, Texas, 76508, United States

Location

Primary Children's Medical Center

Salt Lake City, Utah, 84113-1100, United States

Location

Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Central Nervous System Neoplasms; Vomiting; Nausea; Oligodendroglioma; Astrocytoma; Choroid Plexus Neoplasms; Meningioma

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Cerebral Ventricle Neoplasms; Brain Neoplasms; Brain Diseases; Central Nervous System Diseases; Neoplasms, Vascular Tissue; Meningeal Neoplasms

Results Point of Contact

• Title: Thomas W. McLean, MD
• Organization: Wake Forest University School of Medicine

tmclean@wfubmc.edu

336-716-4085

Study Officials

• Thomas Williams McLean, MD

  Wake Forest University Health Sciences

  STUDY CHAIR

• Lee Dupuis, PhD

  The Hospital for Sick Children

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2011
• First Posted: May 2, 2011
• Study Start: May 1, 2011
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: August 18, 2021
• Results First Posted: June 25, 2021

Record last verified: 2017-10

Locations

US (24); CA (1)