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| Tracking Information | |||||
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| First Received Date ICMJE | November 1, 1999 | ||||
| Last Updated Date | August 19, 2009 | ||||
| Start Date ICMJE | October 1999 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00003817 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy | ||||
| Official Title ICMJE | 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. |
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| 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. |
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| Study Phase | Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Supportive Care, Randomized | ||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Publications * | 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. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Estimated Enrollment ICMJE | 700 | ||||
| Completion Date | |||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | 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 |
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00003817 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | CDR0000066969, URCC-U3997, NCI-V99-1528 | ||||
| Study Sponsor ICMJE | James P. Wilmot Cancer Center | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||
| Verification Date | May 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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