Acute Pain Caused by Paclitaxel in Patients With Cancer

Alliance for Clinical Trials in Oncology306 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

306

Conditions

Chemotherapeutic Agent Toxicity Neurotoxicity Pain Unspecified Adult Solid Tumor, Protocol Specific

Interventions

pain questionnairesBEHAVIORAL

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

DISEASE CHARACTERISTICS: * Diagnosis of cancer * Planning to receive paclitaxel IV (excluding paclitaxel albumin-stabilized nanoparticle formulation \[nab-paclitaxel\]) according to one of the following dosing schedules: * At least 175 mg/m\^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively) * 70-90 mg/m\^2 weekly (3 out of 4 weeks allowed) PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Life expectancy \> 6 months * Able to complete questionnaires (alone or with assistance) * Willing to provide required biological specimens * No prior or concurrent peripheral neuropathy (from diabetes or other causes) * No prior or concurrent fibromyalgia PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior paclitaxel or neurotoxic chemotherapy drugs, including other taxanes, platinum agents, vinca alkaloids, or epothilones * No concurrent neutrophil colony-stimulating factor therapy

Locations (279)

Outcomes

Primary Outcomes

Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy)

Time frame: Up to day 7

Secondary Outcomes

Maximum of the average pain score

Time frame: Up to 12 months

Area under the curve of worst, average, and least pain

Time frame: Up to 12 months

Worst pain reported for the overall week

Time frame: Up to 12 months

Rate of non-prescription pain medication use

Time frame: Up to 12 months

Rate of opioid use

Time frame: Up to 12 months

Rate of other pain therapy use

Time frame: Up to 12 months

Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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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