NCT01096407

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.

• Status: Terminated
• Phase: —
• Study type: Observational
• Enrollment: 5 (actual)
• Sponsor: Vanderbilt-Ingram Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

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.

Conditions

• Arthralgia
• Pain
• Unspecified Adult Solid Tumor, Protocol Specific

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis	Collection of urine samples
OTHER	questionnaire administration	Completion of questionnaires
PROCEDURE	assessment of therapy complications	An assessment will be completed.

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-11-01
• Completion: 2010-11-01
• First posted: 2010-03-31
• Last updated: 2013-04-04

Locations

2 sites across 1 country: United States