Clinical trial · Interventional
Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib
Prevention of Taxane-associated Acute Pain Syndrome With Etoricoxib for Breast Cancer Patients: A Phase II Randomized Trial
NCT04565600CI-TRIAL-00056507completedPhase 2ClinicalTrials.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)
A phase II randomized clinical trial was conducted to determine whether etoricoxib could prevent or ameliorate the incidence and/or severity of docetaxel-induced acute pain syndrome. We also aimed to determine if there are any improvement of the late-onset peripheral neuropathy as well as quality of life with prophylactic etoricoxib for breast cancer patients who receive docetaxel chemotherapy.
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 |
|---|---|---|---|
| Pain Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Etoricoxib | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Etoricoxib
- description
- Prophylactic etoricoxib (60 mg) was administered orally at each course of docetaxel-containing chemotherapy, which started from the day of chemotherapy and was performed once per day for 8 days (day 1-8).
- interventionNames
- Drug: Etoricoxib
- type
- NO_INTERVENTION
- label
- Control
- description
- No prophylactic regimen was given.
Primary outcomes (1)
- measure
- overall incidence of taxane-associated acute pain syndrome across all cycles of chemotherapy
- timeFrame
- 6 months
- description
- Total incidence of myalgia and arthralgia of patients across all cycles of docetaxel chemotherapy
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Age ≥18 years * Stage I-III breast cancer * ECOG 0-2 * Received docetaxel-containing chemotherapy Exclusion Criteria: * Existed any chronic pain or peripheral neuropathy * Prior history of gastrointestinal bleeding or ulcer * Long-term history of receiving oral corticoids, nonsteroid anti-inflammatory drugs (NSAIDs) or anti-histamines * Allergies to NSAIDs or aspirin * Blood creatinine level exceeds 1.5 times of the upper limit of normal range
References
Publications (1)
- DERIVEDZhang J, Gao HF, Yang C, Zhu T, Ji F, Yang M, Zhang L, Li J, Cheng M, Zhang T, Shen B, Chen Y, Wang K. Prevention of taxane-associated acute pain syndrome with etoricoxib for patients with breast cancer: A phase II randomised trial. Eur J Cancer. 2022 Aug;171:150-160. doi: 10.1016/j.ejca.2022.05.019. Epub 2022 Jun 17. PMID 35724467