Trial Information

A Randomized Phase II Trial of Acupressure and Acustimulation Wrist Bands for the Prevention of Chemotherapy-Induced Nausea and Vomiting

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.