Nausea or Vomiting in Patients Who Are Receiving Chemotherapy for Breast Cancer or Lung Cancer

Breast Cancer Clinical Trial

Official title:

Determination of Utilities for Control of Chemotherapy-Induced Nausea or Vomiting

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00416689
• Other study ID #: CALGB-309801
• Secondary ID: U10CA031946CALGB
• Status: Completed
• Phase: N/A
• First received: December 27, 2006
• Last updated: June 28, 2016
• Start date: April 2000
• Est. completion date: January 2006

Study information

• Verified date: June 2016
• Source: Alliance for Clinical Trials in Oncology
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

RATIONALE: Understanding how nausea or vomiting caused by chemotherapy effects a patient's treatment decisions may help doctors plan better cancer treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is studying nausea or vomiting in patients who are receiving chemotherapy for breast cancer or lung cancer.

Description:

OBJECTIVES:

• Determine the contribution of nausea or vomiting to the overall importance for a current state of health in patients with breast or lung cancer undergoing chemotherapy.

• Determine the average importance for various emetic scenarios in these patients.

• Compare the importance of a specific level of chemotherapy-induced nausea or vomiting, defined by the Standard Gamble vs Morrow Assessment of Nausea and Emesis.

• Determine the feasibility of using a Standard Gamble technique in patients currently undergoing chemotherapy.

OUTLINE: This is a multicenter study. Patients are stratified according to history of chemotherapy-induced nausea or vomiting (yes vs no).

Patients undergo a structured interview over 1 hour by a trained interviewer at least 2½ weeks after initiation of the most recent course of chemotherapy and before the new course is administered. Patients complete a Functional Assessment of Cancer Therapy-General questionnaire and Morrow Assessment of Nausea and Emesis questionnaire during the interview. The trained interviewer also administers a Standard Gamble exercise during the interview, in which patients are instructed to imagine various amounts of nausea or vomiting as their current state of nausea and vomiting, and rank their importance to them. They are being asked to answer the question of whether they would choose to accept their current (imagined or real) state of nausea or vomiting or receive a medication that would result (with various probabilities) in either perfect health for 2 years or immediate death.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: January 2006
• Est. primary completion date: March 2003
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of breast cancer or lung cancer

• Must be undergoing chemotherapy with each course lasting 3-6 weeks AND meets all of the following criteria:

• Completed = 1 course with = 1 additional course planned

• At least 2½ weeks since initiation of the most recent course of chemotherapy

PATIENT CHARACTERISTICS:

• Common Toxicity Criteria performance status 0-2

• Must have command of written and/or spoken English

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Lung Cancer
• Lung Neoplasms
• Nausea
• Nausea and Vomiting
• Vomiting

Intervention

Procedure:
• assessment of therapy complications

• quality-of-life assessment

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Alliance for Clinical Trials in Oncology	National Cancer Institute (NCI)