Trial record 11 of 22 for:    native american AND (woman OR women OR female)

Acute Pain Caused by Paclitaxel in Patients With Cancer

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by National Cancer Institute (NCI).
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00860041
First received: March 10, 2009
Last updated: April 26, 2011
Last verified: April 2011
  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
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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 360
Study Start Date: February 2009
Estimated Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00860041

  Show 271 Study Locations
Sponsors and Collaborators
North Central Cancer Treatment Group
Investigators
Principal Investigator: Charles L. Loprinzi, MD Mayo Clinic
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00860041     History of Changes
Other Study ID Numbers: CDR0000631962, NCCTG-N08C1
Study First Received: March 10, 2009
Last Updated: April 26, 2011
Health Authority: Unspecified

Keywords provided by National Cancer Institute (NCI):
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
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 18, 2014