Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis (0000-041)

Chemotherapy Induced Nausea and Vomiting Clinical Trial

— C-PHONE  

Official title:

Study of Chemotherapy and Patient Health Outcomes for Nausea and Emesis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00211601
• Other study ID #: 0000-041
• Secondary ID: 0412005_072
• Status: Completed
• Phase: N/A
• First received: September 13, 2005
• Last updated: April 30, 2015
• Start date: August 2004
• Est. completion date: December 2005

Study information

• Verified date: April 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1500
• Est. completion date: December 2005
• Est. primary completion date: December 2005
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Chemotherapy Induced Nausea and Vomiting
• Nausea

Intervention

Behavioral:
• Disease Management Assessment

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	CINV at the delayed phase during cycle 2
Secondary	Treatment for CINV