Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outline
Trial Contact Information

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Supportive care Closed 18 to 90 URCC-2988P-M NCI-P89-0016, NCI-C88-0004

Objectives

I.  Assess the degree to which behavioral relaxation, anti-anxiety medication, 
or their combination can reduce patient anxiety during chemotherapy treatment.

II.  Assess systematically the effect of anxiety reduction on chemotherapy 
side effects of nausea and vomiting in addition to other quality of life areas.

Entry Criteria

Disease Characteristics:

See General Eligibility Criteria

Patient Characteristics:

See General Eligibility Criteria

General Eligibility Criteria:

Patients between 18 and 90 years of 
age who have had no more than 1 chemotherapy regimen in the ambulatory medical 
oncology units of the participating hospitals.  There must be no evidence that 
the nausea and vomiting are the result of such physiologic phenomena as 
mechanical obstruction of the gastrointestinal tract by tumor, metabolic 
changes, or brain metastases.  Concurrent radiotherapy is not allowed.  A 
sensitivity to benzodiazepines or chemotherapy within the last 6 months 
excludes, and patients must not be presently taking other psychotropic drugs.  
Patients with a history of alcohol abuse, drug addiction, or major mental 
illness are ineligible.  An ability to communicate verbally in English is 
required.

Expected Enrollment

50 evaluable patients per arm will be entered by CCOP institutions.

Outline

Randomized study.

Arm I:  Management of Nausea and Vomiting.  Relaxation intervention.

Arm II:  Management of Nausea and Vomiting.  Alprazolam.

Arm III:  Management of Nausea and Vomiting.  Relaxation intervention plus 
Alprazolam.

Arm IV:  Control.  Observation only.

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