Clinical trial · Observational
Taxane Acute Pain Syndrome (TAPS) in Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer
A Multi-Centre Study to Investigate the Natural History of Taxane Acute Pain Syndrome (TAPS) in Patients Receiving Taxane Chemotherapy for Breast or Prostate Cancer
- 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)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Pain | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Quality of life and brief pain inventory | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- The incidence of TAPS
- timeFrame
- Every 21 days over 12 weeks
- description
- Participant will be asked prior to each taxane chemotherapy if they experienced TAPS and complete quality of life questionnaires
Secondary outcomes (3)
- measure
- The intervention used to reduced TAPS severity
- timeFrame
- Every 21 days over 12 weeks
- description
- The intervention used to reduced TAPS severity including 1. Analgesia - pain medication diary 2. Exercise 3. other
- measure
- The TAPS associated treatment modification
- timeFrame
- Every 21 days over 12 weeks
- description
- The TAPS associated treatment modification 1. Taxane dose reduction 2. Chemotherapy treatment delay 3. Taxane discontinuation i. No further treatment pursued ii. Or Switch to non-taxane chemotherapy due to taxane toxicity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Diagnosed with either invasive breast or prostate cancer (stage I-IV) * Age ≥18 years * ECOG performance status ≤2 * Scheduled to receive intravenous taxane-based chemotherapy for either adjuvant or metastatic disease * Participants need to have ability to complete questionnaires by themselves or with assistance and have the ability to provide informed written consent Exclusion Criteria: * Concurrent use of any agents to try to prevent or treat neuropathy or TAPS, including gabapentin, glutamine, vitamin B6, and vitamin E. * 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 * Uncontrolled diabetes * Medical or psychiatric illness that would interfere with patients' ability to complete the diary
References
Publications (0)
Data not yet available