Acupressure and Acustimulation Wrist Bands for the Prevention of Nausea and Vomiting Caused by Chemotherapy
Condition: Nausea and Vomiting; Unspecified Adult Solid Tumor, Protocol Specific
MeSH terms: Nausea; Vomiting
Study type: Interventional
Phase: Phase 2

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.
    

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.
    

Intervention name(s): dolasetron mesylate; granisetron hydrochloride; ondansetron; tropisetron; quality-of-life assessment
Intervention type(s): Drug; Drug; Drug; Drug; Procedure
Intervention MeSH terms: Ondansetron; Granisetron; Tropisetron; Dolasetron
Allocation: Randomized
Primary purpose: Supportive Care
Keywords: unspecified adult solid tumor, protocol specific; nausea and vomiting