Trials / Completed
CompletedNCT00860041
Acute Pain Caused by Paclitaxel in Patients With Cancer
Paclitaxel-Associated Acute Pain Syndrome Natural History Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 306 (actual)
- Sponsor
- Alliance for Clinical Trials in Oncology · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | pain questionnaires |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2011-04-01
- Completion
- 2013-05-01
- First posted
- 2009-03-11
- Last updated
- 2016-07-14
Locations
279 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00860041. Inclusion in this directory is not an endorsement.