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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier:
NCT00416689
First received: December 27, 2006
Last updated: September 29, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Breast Cancer
Lung Cancer
Nausea and Vomiting
Procedure: assessment of therapy complications
Procedure: quality-of-life assessment

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Determination of Utilities for Control of Chemotherapy-Induced Nausea or Vomiting

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Enrollment: 99
Study Start Date: April 2000
Study Completion Date: January 2006
Primary Completion Date: March 2003 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Breast or lung CA pt undergoing chemoTx Procedure: assessment of therapy complications Procedure: quality-of-life assessment

Detailed 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.

PROJECTED ACCRUAL: A total of 140 patients will be accrued for this study.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Breast or lung cancer patients undergoing chemotherapy

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00416689

Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
Investigators
Study Chair: Steven M. Grunberg, MD University of Vermont
  More Information

Additional Information:
No publications provided

Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00416689     History of Changes
Other Study ID Numbers: CDR0000460041, U10CA031946, CALGB-309801
Study First Received: December 27, 2006
Last Updated: September 29, 2013
Health Authority: United States: Federal Government

Keywords provided by Alliance for Clinical Trials in Oncology:
nausea and vomiting
pulmonary carcinoid tumor
recurrent breast cancer
stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
recurrent non-small cell lung cancer
stage I non-small cell lung cancer
stage II non-small cell lung cancer
stage IIIA non-small cell lung cancer
stage IIIB non-small cell lung cancer
stage IV non-small cell lung cancer
extensive stage small cell lung cancer
limited stage small cell lung cancer
recurrent small cell lung cancer

Additional relevant MeSH terms:
Breast Neoplasms
Lung Neoplasms
Nausea
Vomiting
Breast Diseases
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Signs and Symptoms
Signs and Symptoms, Digestive
Skin Diseases
Thoracic Neoplasms

ClinicalTrials.gov processed this record on October 29, 2014