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

Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01096407
• Other study ID #: VICC SUPP 0928
• Secondary ID: P30CA068485VU-VI
• Status: Terminated
• Phase: Phase 1
• First received: March 30, 2010
• Last updated: April 1, 2013
• Start date: November 2009
• Est. completion date: November 2010

Study information

• Verified date: March 2013
• Source: Vanderbilt-Ingram Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Vanderbilt University Human Research Protection Program
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 5
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Intervention

Other:
• laboratory biomarker analysis
Collection of urine samples
• questionnaire administration
Completion of questionnaires

Procedure:
• assessment of therapy complications
An assessment will be completed.

Locations

Country	Name	City	State
United States	Vanderbilt-Ingram Cancer Center	Nashville	Tennessee
United States	Vanderbilt-Ingram Cancer Center - Cool Springs	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt-Ingram Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	Correlation of urinary PEG-M level with pain	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	No
Secondary	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	No