N/A
Completed N=187
Acupressure in Controlling Nausea in Young Patients Receiving Highly Emetogenic Chemotherapy
Central Nervous System Tumor, Pediatric · Chemotherapy-Induced Nausea and Vomiting · Unspecified Childhood Solid Tumor, Protocol Specific
Source: ClinicalTrials.gov NCT01346267 ↗
Enrolled (actual)
187
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcomePrimary: Efficacy of Treatment on CIN During Acute Phase of Chemotherapy — 37; 41; 17; 8 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy of Treatment on CIN During Acute Phase of Chemotherapy |
37; 41; 17; 8; 16; 19 | — |
| SECONDARY Efficacy of Treatment on CIN During Delayed Phase of Chemotherapy |
27; 27; 19; 15; 19; 13 | — |
| SECONDARY Comparison of Control of CIV During the Acute and Delayed Phase of Chemotherapy |
17; 19; 43; 48; 23; 15 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT01346267). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.