Role of Biomarkers in Muscle Pain and Joint Pain in Patients With Solid Tumors Receiving Paclitaxel
The Role of COX-2 Mediated Prostaglandin Production on Paclitaxel-Induced Myalgias and Arthralgias.
RATIONALE: Learning about pain in patients with cancer receiving paclitaxel may help plan treatment and may help patients live more comfortably. Studying samples of urine from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to muscle and joint pain.
PURPOSE: This phase I trial is studying the role of biomarkers in muscle pain and joint pain in patients with solid tumors receiving paclitaxel.
Study Overview
Status
Detailed Description
OBJECTIVES:
Primary
- To determine the change in urinary prostaglandin E metabolite (PGE-M) level after paclitaxel treatment in patients with a variety of solid tumor malignancies.
- To determine whether a change in PGE-M level correlates with paclitaxel dose.
- To determine whether the change in urinary PGE-M level correlates with patient reporting of pain, as measured by a visual analog scale and the Brief Pain Inventory short form (BPI-SF).
Secondary
- To determine whether leukotriene levels are affected by paclitaxel treatment.
OUTLINE: At baseline (prior to the first dose of paclitaxel), patients complete a questionnaire about their baseline pain symptoms (including the Brief Pain Inventory short form and the visual analog scale); cigarette smoking status and second-hand smoke exposure; and routine use of any pain medications (including NSAIDs, selective COX-2 inhibitors, and opioid analgesics), corticosteroids, or leukotriene antagonists (montelukast or zafirlukast). Patients also complete questionnaires about their pain daily on days 2-7 after paclitaxel administration.
Urine samples are collected at baseline for urinary prostaglandin E metabolite (PGE-M), urinary leukotriene E_4 (LTE_4), and urinary cotinine levels and on day 4 for urinary PGE-M and LTE_4 levels.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37232-6838
- Vanderbilt-Ingram Cancer Center
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Nashville, Tennessee, United States, 37064
- Vanderbilt-Ingram Cancer Center - Cool Springs
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
DISEASE CHARACTERISTICS:
- Solid malignancy of any type
Patients must be scheduled to receive their first dose of paclitaxel at Vanderbilt-Ingram Cancer Center
- Any paclitaxel-containing regimen or dosing schedule is allowed
PATIENT CHARACTERISTICS:
- Not pregnant
- Accessible for follow-up
- Able to submit urine samples
- Able to complete questionnaires
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Paclitaxel-Induced Myalgias/Arthralgias
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Collection of urine samples
Completion of questionnaires
An assessment will be completed.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in urinary PGE-M level after paclitaxel treatment
Time Frame: Day 1 before paclitaxel treatment and day 4, after treatment
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Change in amount of PGE-M in the urine from before administration of paclitaxel to 4 days after treatment.
|
Day 1 before paclitaxel treatment and day 4, after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Correlation of change in urinary PEG-M level and paclitaxel dose
Time Frame: Day 1 before paclitaxel treatment and day 4, after treatment
|
Inter-relationship between the dose of paclitaxel and the change in level of urinary PEG-M from before treatment compared to day 4 of paclitxel treatment
|
Day 1 before paclitaxel treatment and day 4, after treatment
|
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Correlation of urinary PEG-M level with pain
Time Frame: day 1 before paclitaxel treatment and day 4, after treatment
|
Inter-relationship between the level of urinary PEG-M level with level of pain, measured from before treatment compared to day 4 after paclitaxel treatment.
Pain is measured on the Brief Pain Inventory (BPI).
The BPI consists of 7 questions about interference of pain in daily life, answered on a scale of 0 (does not interfere) to 10 (completely interferes).
The summary score is the average of the 7 scores, with higher scores indicating greater interference with pain.
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day 1 before paclitaxel treatment and day 4, after treatment
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Change in urinary luekotriene E_4 level after paclitaxel treatment
Time Frame: day 1 before paclitaxel treatment and day 4, after treatment
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Inter-relationship be the level of urinary luekotriene E_4 from before treatment compared to day 4 after paclitaxel treatment
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day 1 before paclitaxel treatment and day 4, after treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jill Gilbert, M.D., Vanderbilt-Ingram Cancer Center
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC SUPP 0928
- P30CA068485 (U.S. NIH Grant/Contract)
- VU-VICC-SUPP-0928
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