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Nasopharyngeal CarcinomaPhase 2NCT02022293

Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis

A Phase 2 study testing Atorvastatin in people with Nasopharyngeal Carcinoma and Radiation Therapy Complication, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 6 sites in China.

Suspended

Paused. Enrolment is on hold for now and may resume.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 40 to 65 years
What is being tested?
Atorvastatin
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
324 participants
Where
6 sitesChina
Study dates
Jan 2017to Jan 2024
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 40 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

6 sites in 1 country.

6 sites in 1 country

China6 sites

  • Dongguan People's Hospital

    Dongguan, Guangdong, 523059

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

  • Zengcheng People's Hospital

    Licheng, Guangdong, 511300

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, Guangxi, 530021

  • The Affiliated Hospital of Guangdong Medical College

    Zhanjiang, Guangdong, 524001

Other trials in China

About this study

Official title: Atorvastatin in Preventing Nasopharyngeal Carcinoma Patients Receiving Radiotherapy From Carotid Stenosis: A Multicenter, Double-blind, Placebo-Controlled, Randomized Trial

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.

Read the detailed description

It is 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 (20mg per night, totally 2 years) or placebo group. All Patients will be followed up for 2 years. Ultrasound and Transcranial Color Doppler (TCD) will be used to evaluate the changes of intima-media thickness (IMT) and occurrence of plaque formation of carotid arteries. Safety will be monitored every 6 months.

Being tested
Atorvastatin, Placebo
Keywords
Nasopharyngeal Carcinoma, Radiotherapy, Carotid Stenosis, Atorvastatin
Medical subject headings
Nasopharyngeal Carcinoma, Carotid Stenosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AtorvastatinDrug

    Also called Atorvastatin Calcium Tablets, Lipitor

    Patients in this group will take 20mg per night.

  • PlaceboOther

Study groups in NCT02022293
Study groupRoleWhat they receive
AtorvastatinActive comparatorPatients will take atorvastatin 20mg per night, totally 2 years.
Receives: Drug: Atorvastatin
PlaceboPlacebo comparatorPatients will take placebo once per night for 2 years. The appearance and dosage of placebo will be the same as atorvastatin.
Receives: Other: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change from baseline in maximal of IMT of bilateral carotid arteries

    Patients will take Ultrasound and Transcranial Color Doppler every 6 months to measure the thickness of intima-media thickness (IMT) and occurrence of plaque formation of carotid arteries. We will compare the maximal IMT of bilateral carotid arteries at 2 years from baseline.

    Measured: At baseline and 2 years

Secondary outcomes (2)

  1. Incidence of sever carotid stenosis

    Patients will be followed up for 2 years. We defined sever carotid stenosis as stenosis>50% by using ultrasound and TCD.

    Measured: At 2 years

  2. Incidence of cardiovascular events

    Patients will be followed up for 2 years and cardiovascular events such as stroke, transient ischemic attack (TIA) will be recorded.

    Measured: At 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Dec 2013 (estimated)
  2. Study startJan 2017
  3. Primary completionDec 2023 (estimated)
  4. Study completionJan 2024 (estimated)

Why it stopped: Enrollment target could not be achieved.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
324 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02022293
Sponsor's protocol ID
2013018
Other IDs
SYSN003
Status last verified
Dec 2017
First submitted
11 Dec 2013
Last updated
4 Dec 2017
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Atorvastatin in people with Nasopharyngeal Carcinoma and Radiation Therapy Complication, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 6 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: paused, as of the sponsor's last update on 4 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in maximal of IMT of bilateral carotid arteries (time frame: At baseline and 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02022293.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2017.

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