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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00416689
Enrollment
99
Registered
2006-12-28
Start date
2000-04-30
Completion date
2006-01-31
Last updated
2016-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Lung Cancer, Nausea and Vomiting

Keywords

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

Brief 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.

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.

Interventions

PROCEDUREassessment of therapy complications
PROCEDUREquality-of-life assessment

Sponsors

National Cancer Institute (NCI)
CollaboratorNIH
Alliance for Clinical Trials in Oncology
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion 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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026