Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy

Study Description

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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.

Condition or disease	Intervention/treatment	Phase
Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific	Drug: dolasetron mesylate; Drug: granisetron hydrochloride; Drug: ondansetron; Drug: tropisetron; Procedure: quality-of-life assessment	Phase 2

Detailed Description:

OBJECTIVES: I. Evaluate the efficacy of acupressure and acustimulation as adjuncts to standard serotonin antiemetics in reducing acute nausea (day of treatment) and delayed nausea (1-4 days following treatment) associated with cisplatin or doxorubicin based chemotherapy in cancer patients. II. Evaluate the efficacy of acupressure and acustimulation in reducing acute and delayed vomiting and in improving quality of life in cancer patients. III. Investigate the relationship between expectations for the development of chemotherapy-related nausea/vomiting and its actual occurrence in cancer patients.

OUTLINE: This is a randomized study. Patients are stratified according to chemotherapy agent and research site. Patients are randomized to one of three treatment arms. Arm I: Patients receive standard antiemetic therapy with serotonin receptor antagonists. Arm II: Patients receive standard antiemetic therapy with serotonin receptor antagonists and wear an acupressure wrist band (an elastic band equipped with a small plastic button used to apply pressure to a specific point on the wrist) continuously for 5 consecutive days except when necessary to avoid immersion in water. Patients may wear the band on either wrist, including alternating between wrists if desired. Arm III: Patients receive standard antiemetic therapy with serotonin receptor antagonists and wear an acustimulation wrist band (a portable transcutaneous electrical nerve stimulator (TENS) device) continuously for 5 consecutive days except when necessary to avoid immersion in water. Patients may wear the band on either wrist, including alternating between wrists if desired, and may adjust the intensity of stimulation for optimum effectiveness. All patients complete a questionnaire concerning expectations of nausea and other side effects prior to receiving chemotherapy with cisplatin and doxorubicin. Patients in arms II and III complete this measure after the wrist band is in position. All patients complete a questionnaire and a 5 day diary at home concerning nausea and emesis following the first chemotherapy treatment, and then complete a quality of life questionnaire on the fourth day following treatment.

PROJECTED ACCRUAL: A total of 700 patients will be accrued for this study over 3 years.

Study Design

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Study Type :	Interventional (Clinical Trial)
Estimated Enrollment :	700 participants
Allocation:	Randomized
Primary Purpose:	Supportive Care
Official Title:	A Randomized Phase II Trial of Acupressure and Acustimulation Wrist Bands for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Study Start Date :	October 1999
Actual Primary Completion Date :	July 2001
Actual Study Completion Date :	July 2001

Arms and Interventions

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Outcome Measures

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Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 120 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

United States, New Jersey
Hackensack University Medical Center
Hackensack, New Jersey, United States, 07601
United States, New York
University of Rochester Cancer Center
Rochester, New York, United States, 14642

Sponsors and Collaborators

Gary Morrow

National Cancer Institute (NCI)

Investigators

Study Chair:	Gary R. Morrow, PhD, MS	James P. Wilmot Cancer Center

More Information

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Publications of Results:

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.

Responsible Party:	Gary Morrow, Director, University of Rochester NCORP Research Base, University of Rochester NCORP Research Base
ClinicalTrials.gov Identifier:	NCT00003817 History of Changes
Other Study ID Numbers:	CDR0000066969; URCC-U3997; NCI-V99-1528
First Posted:	March 23, 2004
Last Update Posted:	October 15, 2015
Last Verified:	October 2015

Keywords provided by Gary Morrow, University of Rochester NCORP Research Base:

unspecified adult solid tumor, protocol specific; nausea and vomiting

Additional relevant MeSH terms:

Nausea; Vomiting; Signs and Symptoms, Digestive; Signs and Symptoms; Ondansetron; Granisetron; Tropisetron; Dolasetron; Antiemetics; Autonomic Agents; Peripheral Nervous System Agents; Physiological Effects of Drugs	Gastrointestinal Agents; Antipruritics; Dermatologic Agents; Serotonin Antagonists; Serotonin Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Antipsychotic Agents; Tranquilizing Agents; Central Nervous System Depressants; Psychotropic Drugs; Anti-Anxiety Agents