Clinical trial · Observational
Acute Pain Caused by Paclitaxel in Patients With Cancer
Paclitaxel-Associated Acute Pain Syndrome Natural History Study
NCT00860041CI-TRIAL-00023073completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chemotherapeutic Agent Toxicity | — | UNRESOLVED | — |
| Neurotoxicity | — | UNRESOLVED | — |
| Pain | — | UNRESOLVED | — |
| Unspecified Adult Solid Tumor, Protocol Specific | Adult Solid Neoplasm | ALIAS | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| pain questionnaires | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (4)
- label
- Group I
- description
- 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.
- interventionNames
- Behavioral: pain questionnaires
- label
- Group II
- description
- 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.
- interventionNames
- Behavioral: pain questionnaires
- label
- Group III
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- RESULTReeves BN, Dakhil SR, Sloan JA, Wolf SL, Burger KN, Kamal A, Le-Lindqwister NA, Soori GS, Jaslowski AJ, Kelaghan J, Novotny PJ, Lachance DH, Loprinzi CL. Further data supporting that paclitaxel-associated acute pain syndrome is associated with development of peripheral neuropathy: North Central Cancer Treatment Group trial N08C1. Cancer. 2012 Oct 15;118(20):5171-8. doi: 10.1002/cncr.27489. Epub 2012 Mar 13. PMID 22415454
- RESULTLoprinzi CL, Reeves BN, Dakhil SR, Sloan JA, Wolf SL, Burger KN, Kamal A, Le-Lindqwister NA, Soori GS, Jaslowski AJ, Novotny PJ, Lachance DH. Natural history of paclitaxel-associated acute pain syndrome: prospective cohort study NCCTG N08C1. J Clin Oncol. 2011 Apr 10;29(11):1472-8. doi: 10.1200/JCO.2010.33.0308. Epub 2011 Mar 7. PMID 21383290
- RESULTReeves B, Dakhil SR, Sloan JA, et al.: Paclitaxel-associated acute pain syndrome (P-APS) and its association on the development of peripheral neuropathy: NCCTG trial N08C1. [Abstract] J Clin Oncol 29 (Suppl 15): A-9047, 2011.