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Acute Pain Caused by Paclitaxel in Patients With Cancer

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00860041
First Posted: March 11, 2009
Last Update Posted: July 14, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Alliance for Clinical Trials in Oncology
  Purpose

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
Chemotherapeutic Agent Toxicity Neurotoxicity Pain Unspecified Adult Solid Tumor, Protocol Specific Behavioral: pain questionnaires

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Paclitaxel-Associated Acute Pain Syndrome Natural History Study

Resource links provided by NLM:


Further study details as provided by Alliance for Clinical Trials in Oncology:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Enrollment: 306
Study Start Date: February 2009
Study Completion Date: May 2013
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.
Behavioral: pain questionnaires
Group II
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.
Behavioral: pain questionnaires
Group III
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.
Behavioral: pain questionnaires
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.
Behavioral: pain questionnaires

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with cancer who are planning to receive paclitaxel IV at least 175 mg/m^2 at 2-4 week intervals (course duration of 2, 3, or 4 weeks, respectively) or 70-90 mg/m^2 weekly (3 out of 4 weeks allowed).
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00860041


  Show 279 Study Locations
Sponsors and Collaborators
Alliance for Clinical Trials in Oncology
National Cancer Institute (NCI)
Investigators
Principal Investigator: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Publications:
Responsible Party: Alliance for Clinical Trials in Oncology
ClinicalTrials.gov Identifier: NCT00860041     History of Changes
Other Study ID Numbers: NCCTG-N08C1
NCI-2009-01108 ( Registry Identifier: CTRP (Clinical Trials Reporting System) )
CDR0000631962 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: March 10, 2009
First Posted: March 11, 2009
Last Update Posted: July 14, 2016
Last Verified: July 2016

Keywords provided by Alliance for Clinical Trials in Oncology:
pain
neurotoxicity
chemotherapeutic agent toxicity
unspecified adult solid tumor, protocol specific

Additional relevant MeSH terms:
Acute Pain
Neurotoxicity Syndromes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Poisoning
Chemically-Induced Disorders
Paclitaxel
Albumin-Bound Paclitaxel
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action