Role of Biomarkers in Muscle Pain and Joint Pain in Patients With Solid Tumors Receiving Paclitaxel
|ClinicalTrials.gov Identifier: NCT01096407|
Recruitment Status : Terminated (slow accrual)
First Posted : March 31, 2010
Last Update Posted : April 4, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Arthralgia Pain Unspecified Adult Solid Tumor, Protocol Specific||Other: laboratory biomarker analysis Other: questionnaire administration Procedure: assessment of therapy complications||Phase 1|
- 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).
- 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 :||Observational|
|Actual Enrollment :||5 participants|
|Official Title:||The Role of COX-2 Mediated Prostaglandin Production on Paclitaxel-Induced Myalgias and Arthralgias.|
|Study Start Date :||November 2009|
|Primary Completion Date :||November 2010|
|Study Completion Date :||November 2010|
Other: laboratory biomarker analysis
Collection of urine samplesOther: questionnaire administration
Completion of questionnairesProcedure: assessment of therapy complications
An assessment will be completed.
- Change in urinary PGE-M level after paclitaxel treatment [ Time Frame: Day 1 before paclitaxel treatment and day 4, after treatment ]Change in amount of PGE-M in the urine from before administration of paclitaxel to 4 days after treatment.
- 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
- 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.
- Change in urinary luekotriene E_4 level after paclitaxel treatment [ Time Frame: day 1 before paclitaxel treatment and day 4, after treatment ]Inter-relationship be the level of urinary luekotriene E_4 from before treatment compared to day 4 after paclitaxel treatment
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01096407
|United States, Tennessee|
|Vanderbilt-Ingram Cancer Center - Cool Springs|
|Nashville, Tennessee, United States, 37064|
|Vanderbilt-Ingram Cancer Center|
|Nashville, Tennessee, United States, 37232-6838|
|Principal Investigator:||Jill Gilbert, M.D.||Vanderbilt-Ingram Cancer Center|