Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy
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Purpose
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 | Intervention | 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 |
| Study Type: | Interventional |
| Study Design: | 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 |
| Estimated Enrollment: | 700 |
| Study Start Date: | October 1999 |
| Study Completion Date: | July 2001 |
| Primary Completion Date: | July 2001 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 120 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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 LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT00003817
| 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 | |
| Study Chair: | Gary R. Morrow, PhD, MS | James P. Wilmot Cancer Center |
More Information
Publications:
| 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 |
| Study First Received: | November 1, 1999 |
| Last Updated: | October 13, 2015 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Rochester:
|
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 |
ClinicalTrials.gov processed this record on September 23, 2016