NCT00003817

Brief Summary

RATIONALE: Pressure or nerve stimulation applied to an acupuncture point on the inside of the wrist may help control nausea and vomiting during chemotherapy. PURPOSE: Randomized phase II trial to study the effectiveness of acupressure and acustimulation wrist bands in treating nausea and vomiting in patients undergoing chemotherapy for cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
700

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 1999

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 1999

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 1, 1999

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2001

Completed
2.7 years until next milestone

First Posted

Study publicly available on registry

March 23, 2004

Completed
Last Updated

October 15, 2015

Status Verified

October 1, 2015

Enrollment Period

1.8 years

First QC Date

November 1, 1999

Last Update Submit

October 13, 2015

Conditions

Nausea and VomitingUnspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specificnausea and vomiting

Interventions

dolasetron mesylateDRUG
granisetron hydrochlorideDRUG
ondansetronDRUG
tropisetronDRUG
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: Diagnosis of cancer No symptomatic brain metastases PATIENT CHARACTERISTICS: Age: 18 and over Performance status: Not specified Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Cardiovascular: No cardiac pacemaker Other: No clinical evidence of current or impending bowel obstruction Able to understand English PRIOR CONCURRENT THERAPY: Biologic therapy: No concurrent interferon Chemotherapy: No prior chemotherapy Concurrent cisplatin or doxorubicin based chemotherapy required No multiple day doses of cisplatin, doxorubicin, hexamethylmelamine, dacarbazine, nitrosourea or streptozocin Other concurrent chemotherapy allowed on 1 or multiple days Endocrine therapy: Not specified Radiotherapy: No concurrent radiotherapy Surgery: Not specified Other: Serotonin receptor antagonist antiemetic (ondansetron, granisetron, tropisetron, or dolasetron mesylate) required

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

Hackensack University Medical Center

Hackensack, New Jersey, 07601, United States

Location

University of Rochester Cancer Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

  • Roscoe JA, Morrow GR, Hickok JT, Bushunow P, Pierce HI, Flynn PJ, Kirshner JJ, Moore DF, Atkins JN. The efficacy of acupressure and acustimulation wrist bands for the relief of chemotherapy-induced nausea and vomiting. A University of Rochester Cancer Center Community Clinical Oncology Program multicenter study. J Pain Symptom Manage. 2003 Aug;26(2):731-42. doi: 10.1016/s0885-3924(03)00254-9.

    PMID: 12906958RESULT

MeSH Terms

Conditions

NauseaVomiting

Interventions

dolasetronGranisetronOndansetronTropisetron

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Azabicyclo CompoundsAza CompoundsOrganic ChemicalsIndazolesPyrazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsBridged Bicyclo Compounds, HeterocyclicHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingImidazolesCarbazolesIndolesHeterocyclic Compounds, 3-Ring

Study Officials

  • Gary R. Morrow, PhD, MS

    James P. Wilmot Cancer Center

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Purpose
SUPPORTIVE CARE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Director, University of Rochester NCORP Research Base

Study Record Dates

First Submitted

November 1, 1999

First Posted

March 23, 2004

Study Start

October 1, 1999

Primary Completion

July 1, 2001

Study Completion

July 1, 2001

Last Updated

October 15, 2015

Record last verified: 2015-10

Locations

US(2)