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

NCT01096407 | Terminated

• 3 other identifiers: VICC SUPP 0928P30CA068485VU-VICC-SUPP-0928
• Study Type: observational
• Target: 5
• Locations: 1 country
• Sites: 2

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.

Conditions

Arthralgia; Pain; Unspecified Adult Solid Tumor, Protocol Specific

Keywords

pain; arthralgia; unspecified adult solid tumor, protocol specific

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Correlation of change in urinary PEG-M level and paclitaxel dose

  Day 1 before paclitaxel treatment and day 4, after treatment

• Correlation of urinary PEG-M level with pain

  day 1 before paclitaxel treatment and day 4, after treatment

• Change in urinary luekotriene E_4 level after paclitaxel treatment

  day 1 before paclitaxel treatment and day 4, after treatment

Study Arms (1)

Paclitaxel-Induced Myalgias/Arthralgias

Other: laboratory biomarker analysis; Other: questionnaire administration; Procedure: assessment of therapy complications

Interventions

laboratory biomarker analysis OTHER

Collection of urine samples

Paclitaxel-Induced Myalgias/Arthralgias

questionnaire administration OTHER

Completion of questionnaires

Paclitaxel-Induced Myalgias/Arthralgias

assessment of therapy complications PROCEDURE

An assessment will be completed.

Paclitaxel-Induced Myalgias/Arthralgias

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Cancer patients that will be treated with paclitaxel.

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Vanderbilt-Ingram Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

Vanderbilt-Ingram Cancer Center - Cool Springs

Nashville, Tennessee, 37064, United States

Location

Vanderbilt-Ingram Cancer Center

Nashville, Tennessee, 37232-6838, United States

Location

MeSH Terms

Conditions

Arthralgia; Pain

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Jill Gilbert, M.D.

  Vanderbilt-Ingram Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine; Director, Hematology/Oncology Fellowship Program; Section Chief, Solid Tumor Oncology; Medical Oncologist

Study Record Dates

• First Submitted: March 30, 2010
• First Posted: March 31, 2010
• Study Start: November 1, 2009
• Primary Completion: November 1, 2010
• Study Completion: November 1, 2010
• Last Updated: April 4, 2013

Record last verified: 2013-03

Locations

US (2)