Clinical trial · Interventional
Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis
Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis: A Multicenter, Double-blind, Placebo-Controlled, Randomized Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Enrollment target could not be achieved.
Summary
Brief summary (as posted)
Patients with head and neck cancer who underwent irradiation have a higher risk of developing severe carotid stenosis, and eventually develop to transient ischemic attack or stroke. However, it's still not clear whether early intervene in vascular risk factors is benefit for patients after radiotherapy. Our study aimed to evaluate the feasibility and safety of atorvastatin for preventing NPC patients after radiotherapy from severe carotid stenosis. In a randomized, double-blind, placebo-controlled trial, about 324 nasopharyngeal carcinoma (NPC) patients will be enrolled from six centers in Guangdong Province and randomized 1:1 to atorvastatin group or placebo group.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Nasopharyngeal Carcinoma | Nasopharyngeal Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Radiation Therapy Complication | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Atorvastatin | Drug | — | UNRESOLVED |
| Placebo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Atorvastatin
- description
- Patients will take atorvastatin 20mg per night, totally 2 years.
- interventionNames
- Drug: Atorvastatin
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Patients will take placebo once per night for 2 years. The appearance and dosage of placebo will be the same as atorvastatin.
- interventionNames
- Other: Placebo
Primary outcomes (1)
- measure
- Change from baseline in maximal of IMT of bilateral carotid arteries
- timeFrame
- At baseline and 2 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 40 Years
- Maximum age
- 65 Years
Show eligibility criteria text
Inclusion Criteria: * Patients must have received radiation therapy for histologically confirmed nasopharyngeal carcinoma. * Prior irradiation \<3 years prior to study entry. * Male or fertile women who are willing to take contraception during the trial. * Age 40-65 years old. * Carotid stenosis \< 50%. * LDL-C between 100mg/dL（2.5mmol/L）and 190mg/dL（4.9mmol/L）. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * History of bleeding related to tumor or radiotherapy during or after radiation. * Evidence of tumor invasion to major vessels(for example the carotid artery). * Severe complications, such as history of stroke, myocardial infarction, liver diseases, thyroid dysfunction, inadequately controlled hypertension and epilepsy. * Familial hypercholesterolemia. * Taking lipid-lowing drugs. * Aspartate aminotransferase(AST) or alanine aminotransferase(ALT) \>upper limits of normal (ULN), creatinine \>ULN. * Allergic history of atorvastatin.
References
Publications (0)
Data not yet available