Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy
Information source: National Cancer Institute (NCI)
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Nausea and Vomiting; Quality of Life; Unspecified Adult Solid Tumor, Protocol Specific
Intervention: dolasetron mesylate (Drug); granisetron hydrochloride (Drug); ondansetron (Drug); tropisetron (Drug); quality-of-life assessment (Procedure)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: James P. Wilmot Cancer Center Official(s) and/or principal investigator(s):
Gary R. Morrow, PhD, MS, Study Chair, Affiliation: James P. Wilmot Cancer Center
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.
Clinical Details
Official title: A Randomized Phase II Trial of Acupressure and Acustimulation Wrist Bands for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Study design: Supportive Care, Randomized
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Hackensack University Medical Center, Hackensack, New Jersey 07601, United States
University of Rochester Cancer Center, Rochester, New York 14642, United States
Additional Information
Clinical trial summary from the National Cancer Institute's PDQ® database
Starting date: October 1999
Last updated: May 23, 2008
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