Chemotherapeutic Agent Toxicity, Neurotoxicity, Pain, Unspecified Adult Solid Tumor, Protocol Specific
Conditions
Keywords
pain, neurotoxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific
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.
Interventions
BEHAVIORALpain questionnaires
Sponsors
National Cancer Institute (NCI)
Alliance for Clinical Trials in Oncology
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 non-prescription pain medication use | Up to 12 months |
| Maximum of the average pain score | Up to 12 months |
| Rate of other pain therapy 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 |
| Rate of opioid use | Up to 12 months |
Countries
United States
Outcome results
None listed