Acute Pain Caused by Paclitaxel in Patients With Cancer

Completed

• Conditions: Neurotoxicity; Pain; Unspecified Adult Solid Tumor, Protocol Specific; Chemotherapeutic Agent Toxicity

• Registration Number: NCT00860041
• Lead Sponsor: Alliance for Clinical Trials in Oncology

Brief Summary

RATIONALE: Gathering information over time from patients receiving paclitaxel for cancer may help doctors learn more about pain caused by paclitaxel and plan the best treatment.

PURPOSE: This clinical trial is studying acute pain caused by paclitaxel in patients with cancer.

Detailed Description

OBJECTIVES:

* To describe the incidence and characteristics of and change in pain related to paclitaxel infusions over several courses in patients receiving paclitaxel weekly or every 2-4 weeks with or without neurotoxic chemotherapy.

* To investigate the association between paclitaxel-induced acute pain syndrome symptoms and eventual chemotherapy-induced neuropathy.

* To perform exome-sequencing analysis and identify genetic variants that predict paclitaxel- induced peripheral neuropathy.

* To identify clinical phenotypes associated with paclitaxel toxicity (i.e., acute pain syndrome and neuropathy).

* To explore whether there are any evident differences between results seen in the majority Caucasian population and the minority populations.

OUTLINE: This is a multicenter study. Patients are grouped according to paclitaxel dosing schedule (weekly vs every 2-4 weeks) and concurrent use of neurotoxic agent (yes vs no).

Blood samples are collected at baseline for correlative laboratory studies, including genetic biomarker and polymorphism studies.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-03-10
• Study First Submitted QC: 2009-03-10
• Study First Posted: 2009-03-11
• Primary Completion: 2011-04
• Study Completion: 2013-05
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-12
• Last Update Posted: 2016-07-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 306

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy)	Up to day 7

Secondary Outcome Measures

Name	Time	Method
Rate of other pain therapy use	Up to 12 months
Rate of non-prescription pain medication use	Up to 12 months
Maximum of the average pain score	Up to 12 months
Area under the curve of worst, average, and least pain	Up to 12 months
Worst pain reported for the overall week	Up to 12 months
Rate of opioid use	Up to 12 months
Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores	Up to 12 months

Trial Locations

Locations (275)

Aurora Presbyterian Hospital; 🇺🇸 Aurora, Colorado, United States

Boulder Community Hospital; 🇺🇸 Boulder, Colorado, United States

Penrose Cancer Center at Penrose Hospital; 🇺🇸 Colorado Springs, Colorado, United States

St. Anthony Central Hospital; 🇺🇸 Denver, Colorado, United States

Porter Adventist Hospital; 🇺🇸 Denver, Colorado, United States

Presbyterian - St. Luke's Medical Center; 🇺🇸 Denver, Colorado, United States

St. Joseph Hospital; 🇺🇸 Denver, Colorado, United States

Rose Medical Center; 🇺🇸 Denver, Colorado, United States

CCOP - Colorado Cancer Research Program; 🇺🇸 Denver, Colorado, United States

Swedish Medical Center; 🇺🇸 Englewood, Colorado, United States

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