Skip to main content
OpenTrials
Completed

NCT Number: NCT00860041

Acute Pain Caused by Paclitaxel in Patients With Cancer

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Aurora Presbyterian Hospital, Aurora, Colorado, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

pain questionnaires

Behavioral

Primary outcomes

  1. 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 outcomes

  1. Maximum of the average pain score

    Time frame: Up to 12 months

  2. Area under the curve of worst, average, and least pain

    Time frame: Up to 12 months

  3. Worst pain reported for the overall week

    Time frame: Up to 12 months

  4. Rate of non-prescription pain medication use

    Time frame: Up to 12 months

  5. Rate of opioid use

    Time frame: Up to 12 months

  6. Rate of other pain therapy use

    Time frame: Up to 12 months

  7. Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores

    Time frame: Up to 12 months

Sponsors and collaborators

Lead sponsor

Alliance for Clinical Trials in Oncology

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

Paclitaxel-Associated Acute Pain Syndrome Natural History Study

Important dates

Study start
2009
Primary completion
2011
Study completion
2013
First posted
Mar 11, 2009
Registry last updated
Jul 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.