Acute Pain Caused by Paclitaxel in Patients With Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Paclitaxel-Associated Acute Pain Syndrome Natural History Study

Conditions
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Chemotherapeutic Agent Toxicity, Neurotoxicity, Pain, Unspecified Adult Solid Tumor, Protocol Specific

Intervention / Treatment
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* Behavioral: pain questionnaires


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group I<br>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<br> <br> |
| Group II<br>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<br> <br> |
| Group III<br>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<br> <br> |
| Group IV<br>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<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum of the worst pain scores from the initiation of paclitaxel therapy (day 1) until day 7 (first week of therapy) |  | Up to day 7 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum of the average pain score |  | Up to 12 months | 
| Area under the curve of worst, average, and least pain |  | Up to 12 months | 
| Worst pain reported for the overall week |  | Up to 12 months | 
| Rate of non-prescription pain medication use |  | Up to 12 months | 
| Rate of opioid use |  | Up to 12 months | 
| Rate of other pain therapy use |  | Up to 12 months | 
| Correlation of the worst pain score for the first dose of therapy with subsequent neuropathy scores |  | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pain, neurotoxicity, chemotherapeutic agent toxicity, unspecified adult solid tumor, protocol specific