Home
Search
Study Topics
Glossary
|
|
|
|
|
Sponsors and Collaborators: |
North Central Cancer Treatment Group National Cancer Institute (NCI) |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00860041 |
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.
Condition | Intervention |
---|---|
Cancer-Related Problem/Condition Pain Unspecified Adult Solid Tumor, Protocol Specific |
Drug: paclitaxel Genetic: polymorphism analysis Other: laboratory biomarker analysis Other: questionnaire administration Procedure: assessment of therapy complications |
Study Type: | Observational |
Official Title: | Paclitaxel-Associated Acute Pain Syndrome Natural History Study |
Estimated Enrollment: | 360 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | April 2011 (Final data collection date for primary outcome measure) |
OBJECTIVES:
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).
Patients complete pain questionnaires at baseline, periodically during treatment with paclitaxel, 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Planning to receive paclitaxel (excluding paclitaxel albumin-stabilized nanoparticle formulation [nab-paclitaxel]) according to one of the following dosing schedules:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Principal Investigator: | Charles L. Loprinzi, MD | Mayo Clinic |
Study ID Numbers: | CDR0000631962, NCCTG-N08C1 |
Study First Received: | March 10, 2009 |
Last Updated: | May 1, 2009 |
ClinicalTrials.gov Identifier: | NCT00860041 History of Changes |
Health Authority: | Unspecified |
pain neurotoxicity chemotherapeutic agent toxicity unspecified adult solid tumor, protocol specific |
Neurotoxicity Syndromes Paclitaxel Tubulin Modulators |
Pain Antimitotic Agents Antineoplastic Agents, Phytogenic |
Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Paclitaxel Therapeutic Uses Mitosis Modulators |
Tubulin Modulators Antimitotic Agents Antineoplastic Agents, Phytogenic Pharmacologic Actions |