C-PHONE Study - Full Text View - ClinicalTrials.gov

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00211601

Purpose

The purpose of this study is to assess whether timely feedback to providers on patient experiences with delayed chemotherapy induced nausea and vomiting (CINV) lead to differences in patient outcomes for subsequent cycles.

Condition	Intervention
Chemotherapy Induced Nausea and Vomiting	Behavioral: Disease Management Assessment

MedlinePlus related topics: Nausea and Vomiting

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Educational/Counseling/Training, Randomized, Open Label, Placebo Control, Parallel Assignment
Official Title:	Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (C-PHONE)

Further study details as provided by Merck:

Primary Outcome Measures:

CINV at the delayed phase during cycle 2

Secondary Outcome Measures:

Treatment for CINV

Estimated Enrollment:	1500
Study Start Date:	August 2004

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Highly or moderately emetogenic chemotherapy planned for at least 2 cycles

Exclusion Criteria:

Concurrent other anti-cancer therapy (e.g. radiation, hormone, etc.); vomiting during the 24 hours prior to first chemotherapy cycle; having a disease/condition or taking medication that may cause emesis

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00211601

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Study ID Numbers:	2005_072
Study First Received:	September 13, 2005
Last Updated:	September 13, 2005
ClinicalTrials.gov Identifier:	NCT00211601
Health Authority:	United States: Food and Drug Administration

Study placed in the following topic categories:

Vomiting
Nausea

ClinicalTrials.gov processed this record on January 16, 2009