Role of Biomarkers in Muscle Pain and Joint Pain in Patients With Solid Tumors Receiving Paclitaxel

Vanderbilt University Medical Center

Status

Terminated

Conditions

Unspecified Adult Solid Tumor, Protocol Specific

Arthralgia

Pain

Treatments

Other: questionnaire administration

Other: laboratory biomarker analysis

Procedure: assessment of therapy complications

Study type

Observational

Funder types

Other

NIH

Identifiers

NCT01096407

VICC SUPP 0928

P30CA068485 (U.S. NIH Grant/Contract)

VU-VICC-SUPP-0928

Details and patient eligibility

About

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.

Full 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.

Enrollment

5 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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: