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

April 1, 2013 updated by: Jill Gilbert, MD, Vanderbilt-Ingram Cancer Center

The Role of COX-2 Mediated Prostaglandin Production on Paclitaxel-Induced Myalgias and Arthralgias.

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

5

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Tennessee
      • Nashville, Tennessee, United States, 37232-6838
        • Vanderbilt-Ingram Cancer Center
      • Nashville, Tennessee, United States, 37064
        • Vanderbilt-Ingram Cancer Center - Cool Springs

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Cancer patients that will be treated with paclitaxel.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Paclitaxel-Induced Myalgias/Arthralgias
Other: laboratory biomarker analysis
Collection of urine samples
Other: questionnaire administration
Completion of questionnaires
Procedure: assessment of therapy complications
An assessment will be completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Day 1 before paclitaxel treatment and day 4, after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Day 1 before paclitaxel treatment and day 4, after 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.
day 1 before paclitaxel treatment and day 4, after treatment
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
day 1 before paclitaxel treatment and day 4, after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Jill Gilbert, M.D., Vanderbilt-Ingram Cancer Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2009

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

March 30, 2010

First Submitted That Met QC Criteria

March 30, 2010

First Posted (Estimate)

March 31, 2010

Study Record Updates

Last Update Posted (Estimate)

April 4, 2013

Last Update Submitted That Met QC Criteria

April 1, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VICC SUPP 0928
  • P30CA068485 (U.S. NIH Grant/Contract)
  • VU-VICC-SUPP-0928

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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