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


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Sponsored by:	University of Rochester
Information provided by:	National Cancer Institute (NCI)

Condition	Treatment or Intervention	Phase
unspecified adult solid tumor, protocol specific Quality of Life nausea and vomiting	Drug: cisplatin Drug: dolasetron mesylate Drug: doxorubicin Drug: granisetron Drug: ondansetron Drug: tropisetron	Phase II

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.

PROTOCOL 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.

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Diagnosis of cancer
No symptomatic brain metastases

--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

--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

Gary R. Morrow, Study Chair, University of Rochester