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


Phase 2
18 Years
N/A
Not Enrolling
Both
Nausea and Vomiting, Unspecified Adult Solid Tumor, Protocol Specific

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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.

Inclusion 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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Primary Purpose: Supportive Care

Principal Investigator

Gary R. Morrow, PhD, MS

Investigator Role:

Study Chair

Investigator Affiliation:

James P. Wilmot Cancer Center

Authority:

United States: Federal Government

Study ID:

CDR0000066969

NCT ID:

NCT00003817

Start Date:

October 1999

Completion Date:

July 2001

Related Keywords:

  • Nausea and Vomiting
  • Unspecified Adult Solid Tumor, Protocol Specific
  • unspecified adult solid tumor, protocol specific
  • nausea and vomiting
  • Nausea
  • Vomiting

Name

Location

University of Rochester Cancer CenterRochester, New York  14642
Hackensack University Medical CenterHackensack, New Jersey  07601