Clinical trial NCT01096407: Role of Biomarkers in Muscle Pain and Joint Pain in Patients With Solid Tumors Receiving Paclitaxel
Official title: The Role of COX-2 Mediated Prostaglandin Production on Paclitaxel-Induced Myalgias and Arthralgias.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Arthralgia
Pain
Unspecified Adult Solid Tumor, Protocol Specific
Keywords: pain
arthralgia
unspecified adult solid tumor, protocol specific
Lead sponsor: Vanderbilt-Ingram Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2010-03-31
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Cancer patients that will be treated with paclitaxel.

Brief 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.

Eligibility 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:

* Not pregnant
* Accessible for follow-up
* Able to submit urine samples
* Able to complete questionnaires

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics

Primary outcomes:
measure: Change in urinary PGE-M level after paclitaxel treatment
timeFrame: Day 1 before paclitaxel treatment and day 4, after treatment
Secondary outcomes:
measure: Correlation of change in urinary PEG-M level and paclitaxel dose
timeFrame: Day 1 before paclitaxel treatment and day 4, after treatment
measure: Correlation of urinary PEG-M level with pain
timeFrame: day 1 before paclitaxel treatment and day 4, after treatment
measure: Change in urinary luekotriene E_4 level after paclitaxel treatment
timeFrame: day 1 before paclitaxel treatment and day 4, after treatment
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center - Cool Springs
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt-Ingram Cancer Center
state: Tennessee
Study officials:
affiliation: Vanderbilt-Ingram Cancer Center
name: Jill Gilbert, M.D.
role: PRINCIPAL_INVESTIGATOR
References: