TAPSOTT14-06: Taxane Acute Pain Syndrome (TAPS) in Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer
Study Details
Study Description
Brief Summary
The purpose of this study is to document what course of action physicians choose for their patients when they develop taxane acute pain syndrome (TAPS) and to identify patients at the greatest risk of TAPS by examining specific human genome markers such as single nucleotide polymorphisms (SNPs) and Copy Number Variations (CNVs) that may explain the genetic (hereditary) component.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Outcome Measures
Primary Outcome Measures
- The incidence of TAPS [Every 21 days over 12 weeks]
Participant will be asked prior to each taxane chemotherapy if they experienced TAPS and complete quality of life questionnaires
Secondary Outcome Measures
- The intervention used to reduced TAPS severity [Every 21 days over 12 weeks]
The intervention used to reduced TAPS severity including Analgesia - pain medication diary Exercise other
- The TAPS associated treatment modification [Every 21 days over 12 weeks]
The TAPS associated treatment modification Taxane dose reduction Chemotherapy treatment delay Taxane discontinuation i. No further treatment pursued ii. Or Switch to non-taxane chemotherapy due to taxane toxicity
- Collection of whole blood and archived tissue for future SNP analysis [At baseline and at one month from the end of Taxane chemotherapy]
Profiling of SNPs will aid to understand the genetic basis for TAPS and outcomes. We will also collect serum and plasma for profiling serum metabolites, drug metabolites and correlate with genotypes (SNPs)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Diagnosed with either invasive breast or prostate cancer (stage I-IV)
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Age ≥18 years
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ECOG performance status ≤2
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Scheduled to receive intravenous taxane-based chemotherapy for either adjuvant or metastatic disease
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Participants need to have ability to complete questionnaires by themselves or with assistance and have the ability to provide informed written consent
Exclusion Criteria:
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Concurrent use of any agents to try to prevent or treat neuropathy or TAPS, including gabapentin, glutamine, vitamin B6, and vitamin E.
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Pre-existing history of peripheral neuropathy greater than grade 1 NCI CTCAE version 4.0 from any cause (chemotherapy, diabetes, alcohol, toxin, hereditary, etc.) other medical conditions that would make study participation unreasonably hazardous
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Uncontrolled diabetes
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Medical or psychiatric illness that would interfere with patients' ability to complete the diary
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ricardo Fernandes | Ottawa | Ontario | Canada | K1H 8L6 |
Sponsors and Collaborators
- Ottawa Hospital Research Institute
Investigators
- Principal Investigator: Ricardo Fernandes, MD, The Ottawa Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 20150011-01H