Acute Pain Caused by Paclitaxel in Patients With Cancer

• Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy) [ Designated as safety issue: No ]
  

• Maximum of the average pain score [ Designated as safety issue: No ]
  
• Area under the curve of worst, average, and least pain [ Designated as safety issue: No ]
  
• Development of new aches/pains attributed to paclitaxel [ Designated as safety issue: No ]
  
• Worst pain reported for the overall week [ Designated as safety issue: No ]
  
• Rate of non-prescription pain medication use [ Designated as safety issue: No ]
  
• Rate of opioid use [ Designated as safety issue: No ]
  
• Rate of other pain therapy use [ Designated as safety issue: No ]
  
• Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores [ Designated as safety issue: No ]
  
• Relationship between genetic biomarkers and the worst pain score [ Designated as safety issue: No ]
  
• Differences between the results seen in the majority Caucasian population and the minority population (as a whole and broken down into Hispanic vs Black vs Asian vs Native American vs Pacific Islander) [ Designated as safety issue: No ]
  
• Correlation of baseline pain, baseline analgesic intake, or baseline neuropathy symptoms with the eventual development of paclitaxel-associated acute pain syndrome or neuropathy [ Designated as safety issue: No ]
  

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 a genotype-phenotype correlation study to identify genetic biomarkers that may contribute to the variation observed in paclitaxel-related toxicity using top candidate single nucleotide polymorphisms (SNPs) from a genome-wide SNP association study of 300 human lymphoblastoid cell lines.
• 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).

• Group I: Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
• Group II (closed to accrual as of 12/4/2009): Patients complete pain questionnaires at baseline, 2-8 days after each weekly paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
• Group III (closed to accrual for general population, but remains open to minority accrual only as of 8/7/2009): Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.
• Group IV: Patients complete pain questionnaires at baseline, 2-8 days after each 2-4 week paclitaxel treatment not given in combination with a neurotoxic agent, and then monthly for 1 year. Information about the type, location, and duration of pain and neuropathy as well as types of interventions used to manage the pain symptoms and the patients' pain responses is collected.

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