Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Published Results
Trial Contact Information
Registry Information

Alternate Title

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

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs Phase II Supportive care Closed 18 and over Other URCC-U3997 NCI-V99-1528, NCT00003817

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.

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

Expected Enrollment

A total of 700 patients will be accrued for this study over 3 years.

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.

Roscoe JA, Morrow GR, Hickok JT, et al.: The efficacy of acupressure and acustimulation wrist bands for the relief of chemotherapy-induced nausea and vomiting. A University of Rochester Cancer Center Community Clinical Oncology Program multicenter study. J Pain Symptom Manage 26 (2): 731-42, 2003.[PUBMED Abstract]

Trial Contact Information

Trial Lead Organizations

James P. Wilmot Cancer Center at University of Rochester Medical Center

Gary Morrow, PhD, MS, Protocol chair		Ph: 585-275-5513

Registry Information
Official Title		A Randomized Phase II Trial of Acupressure and Acustimulation Wrist Bands for the Prevention of Chemotherapy-Induced Nausea and Vomiting
Trial Start Date		1999-10-21
Registered in ClinicalTrials.gov		NCT00003817
Date Submitted to PDQ		1999-03-15
Information Last Verified		2007-05-31