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| ID | Type | Description | Link |
|---|---|---|---|
| P30CA068485 | U.S. NIH Grant/Contract | View source | |
| VU-VICC-SUPP-0928 |
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slow accrual
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
OBJECTIVES:
Primary
Secondary
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Paclitaxel-Induced Myalgias/Arthralgias |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| laboratory biomarker analysis | Other | Collection of urine samples |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in urinary PGE-M level after paclitaxel treatment | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Correlation of change in urinary PEG-M level and paclitaxel dose | 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 |
| Correlation of urinary PEG-M level with pain |
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DISEASE CHARACTERISTICS:
Solid malignancy of any type
Patients must be scheduled to receive their first dose of paclitaxel at Vanderbilt-Ingram Cancer Center
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Cancer patients that will be treated with paclitaxel.
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| Name | Affiliation | Role |
|---|---|---|
| Jill Gilbert, M.D. | Vanderbilt-Ingram Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vanderbilt-Ingram Cancer Center - Cool Springs | Nashville | Tennessee | 37064 | United States | ||
| Vanderbilt-Ingram Cancer Center |
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| questionnaire administration | Other | Completion of questionnaires |
|
| assessment of therapy complications | Procedure | An assessment will be completed. |
|
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. |
| day 1 before paclitaxel treatment and day 4, after treatment |
| Change in urinary luekotriene E_4 level after paclitaxel treatment | Inter-relationship be the level of urinary luekotriene E_4 from before treatment compared to day 4 after paclitaxel treatment | day 1 before paclitaxel treatment and day 4, after treatment |
| Nashville |
| Tennessee |
| 37232-6838 |
| United States |
| ID | Term |
|---|---|
| D018771 | Arthralgia |
| D010146 | Pain |
| ID | Term |
|---|---|
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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