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

This study is ongoing, but not recruiting participants.
Information provided by National Cancer Institute (NCI)

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Descriptive Information Fields
Brief Title  Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy
Official Title  A Randomized Phase II Trial of Acupressure and Acustimulation Wrist Bands for the Prevention of Chemotherapy-Induced Nausea and Vomiting
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.

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 Phase Phase II
Study Type  Interventional
Study Design  Supportive Care, Randomized
Primary Outcome Measure 
Secondary Outcome Measure 
Condition  Nausea and Vomiting
Quality of Life
Unspecified Adult Solid Tumor, Protocol Specific
Intervention  Drug: dolasetron mesylate
Drug: granisetron hydrochloride
Drug: ondansetron
Drug: tropisetron
Procedure: quality-of-life assessment
MEDLINE PMIDs 12906958
Links Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site
Recruitment Information Fields
Recruitment Status  Active, not recruiting
Enrollment  700
Start Date  October 1999
Completion Date
Eligibility 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

Gender Both
Ages 18 Years and older
Accepts Healthy Volunteers No
Contacts ††
Location Countries  United States
Administrative Information Fields
NCT ID  NCT00003817
Organization ID CDR0000066969
Secondary IDs †† URCC-U3997, NCI-V99-1528
Study Sponsor  James P. Wilmot Cancer Center
Collaborators ††
Investigators 
Study Chair:     Gary R. Morrow, PhD, MS     James P. Wilmot Cancer Center    
Information Provided By National Cancer Institute (NCI)
Verification Date May 2007
First Received Date  November 1, 1999
Last Updated Date May 23, 2008

 †    Required WHO trial registration data element.
††   WHO trial registration data element that is required only if it exists.




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