Lung Function Testing in Patients With Locally Advanced or Metastatic Solid Tumors

NCT00914147 | Completed DMC

• 3 other identifiers: CDR0000642265P30CA022453WSU-2009-004
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Measuring how well the lungs work in patients with cancer may help doctors predict how patients will respond to treatment and help plan the best treatment. PURPOSE: This clinical trial is studying lung function testing in patients with locally advanced or metastatic solid tumors.

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Keywords

unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• DLCO, FVC, and FEV1 as measured by pulmonary function testing

  Prior to participation in a Phase I trial

Study Arms (1)

Pulmonary Function Test (PFT)

OTHER

After signing consent, patients will undergo a complete spirometry test, lung volumes and diffusing capacity (DLCO) measurement utilizing the single-breath breath holding technique, according to the ATS/ERS consensus and standardization. PFT measurements will be reported as absolute values (e.g. liters) and percentage of predicted. The predicted normal values will be calculated according to sex, age, height and race using the Third National Health and Nutrition Examination Survey (NHANES III) reference equation. Predicted values for diffusion capacity will be calculated using the Morris/Polgar equation. DLCO values will be adjusted to anemia (hemoglobin levels)

Procedure: pulmonary function testing

Interventions

pulmonary function testing PROCEDURE

After signing consent, patients will undergo a complete spirometry test, lung volumes and diffusing capacity (DLCO) measurement utilizing the single-breath breath holding technique, according to the ATS/ERS consensus and standardization.

Also known as: PFT

Pulmonary Function Test (PFT)

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Histologically confirmed solid tumor * Locally advanced or metastatic disease * Disease progressed on or after standard therapy OR there is no standard therapy for the malignancy * Standard therapy is defined as first- or second-line therapy that has been shown to provide clinical benefit * Life-long non-smoker * No lung metastasis and/or pleural effusion causing signs or symptoms that impact patient performance status PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Body mass index ≤ 35 * No concurrent uncontrolled illness including, but not limited to, the following: * Ongoing or active infection * Symptomatic congestive heart failure * Unstable angina pectoris * Ventricular arrhythmia * Psychiatric illness or social situation that would limit compliance with study requirements * No uncontrolled chest or abdominal pain * No oral or facial pain exacerbated by an oral device * No stress incontinence * No COPD, interstitial lung disease, pulmonary embolism, or hemorrhage within the past 6 months * No history of pulmonary fibrosis or pulmonary hypertension * No oxygen requirement at baseline * No asthma * No occupational lung disease, including, but not limited to, asbestos exposure * No polycythemia * No history of connective tissue disease PRIOR CONCURRENT THERAPY: * No prior radiotherapy to the lung * At least 6 months since prior lung surgery * No prior amiodarone hydrochloride * No prior high-dose chemotherapy with autologous or allogeneic hematopoietic stem cell transplantation * No concurrent combination antiretroviral therapy for HIV-positive patients

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Barbara Ann Karmanos Cancer Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Barbara Ann Karmanos Cancer Institute

Detroit, Michigan, 48201-1379, United States

Location

Related Links

• Clinical trial summary from the National Cancer Institute's PDQ® database

MeSH Terms

Interventions

Respiratory Physiological Phenomena

Intervention Hierarchy (Ancestors)

Circulatory and Respiratory Physiological Phenomena

Study Officials

• Ulka N. Vaishampayan, M.D.

  Barbara Ann Karmanos Cancer Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 3, 2009
• First Posted: June 4, 2009
• Study Start: May 1, 2009
• Primary Completion: August 23, 2012
• Study Completion: August 23, 2012
• Last Updated: March 8, 2021

Record last verified: 2020-05

Locations

US (1)