Clinical trial · Interventional

Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy

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

NCT01346267CI-TRIAL-00053376SCUSF1202completedN/AResults postedClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

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

Conditions (3)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Central Nervous System Tumor, Pediatric	Childhood Central Nervous System Neoplasm	ALIAS	0.90
Chemotherapy-induced Nausea and Vomiting	—	UNRESOLVED	—
Unspecified Childhood Solid Tumor, Protocol Specific	Childhood Solid Neoplasm	ALIAS	0.85

Interventions

Interventions (2)

Intervention	Type	Mapped drug	Match
Placebo Acupressure Band	Procedure	—	UNRESOLVED
Real Acupressure Band	Procedure	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm I- Real Acupressure bands
description
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.
interventionNames
1. Procedure: Real Acupressure Band
type
SHAM_COMPARATOR
label
Arm II- Placebo Acupressure Bands
description
Patients wear placebo wristbands on each wrist and receive standard of care anti-emetic prophylaxis during chemotherapy as patients in arm I.
interventionNames
1. Procedure: Placebo Acupressure Band

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 4 Years
Maximum age: 18 Years

Show eligibility criteria text

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

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: May 1, 2011
Primary completion: May 1, 2016
Completion: May 1, 2016
First posted: May 2, 2011
Last update posted: Aug 18, 2021
Results first posted: Jun 25, 2021
Enrollment: 187 (actual)
Lead sponsor: University of South Florida OTHER
Collaborators: National Cancer Institute (NCI)
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