Nasopharyngeal CarcinomaNCT02044562
Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients
A study testing nitrate supplementation in people with Nasopharyngeal Carcinoma, run by Capital Medical University at 1 site in China.
Trial summary
The purpose of this study is to evaluate whether dietary nitrate supplementation could improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy. Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- nitrate supplementation
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Sep 2013to Sep 2014
- Phase
- Interventional
- 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 20 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with newly diagnosed stages III-IVb (UICC 2002) nasopharyngeal carcinomas, will be recruited.
Who cannot join
- Patients with local invasion or metastatic foci in salivary glands, detected by MRI and PET-CT prior to treatment, were excluded, as were patients suffering from diseases, such as Sjogren's syndrome, or with a history of surgery to major salivary glands, or prior head and neck radiotherapy.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Capital Medical University School of Stomatology
Beijing, Beijing Municipality, 100050
Xingmin Qu, 8610-57099421, xingminqu@sina.com
About this study
Official title: Study of Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients Receiving Concurrent Chemo-radiotherapy
The purpose of this study is to evaluate whether dietary nitrate supplementation could improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.
Read the detailed description
Twenty patients diagnosed as nasopharyngeal carcinoma will be recruited. A 70 ml beetroot juice containing 0.45g nitrate or placebo will be provided to the patients for 7 days at the end of the radiotherapy . The plasma nitrate levels will be determined before radiotherapy, before intervention and after intervention.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- nitrate supplementation, Placebo
- Keywords
- dietary nitrate, radiotherapy, nasopharyngeal carcinoma
- Medical subject headings
- Nasopharyngeal Carcinoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nitrate supplementationDietary supplement
A 70 ml beetroot juice containing 0.45g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.
PlaceboDietary supplement
A 70 ml placebo containing 0 g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.
| Study group | Role | What they receive |
|---|---|---|
| nitrate supplementation | Experimental | Patients will receive 7-day nitrate supplementation at the end of the radiotherapy. Receives: Dietary Supplement: nitrate supplementation |
| Placebo | Placebo comparator | Patients will receive 7-day placebo supplementation at the end of the radiotherapy Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
plasma nitrate level
The plasma nitrate level will be determined one day after nitrate supplementation.
Measured: one day after nitrate supplementation
Secondary outcomes (1)
quality of life
The quality of life will be assessed one day after nitrate supplementation.
Measured: one day after nitrate supplementation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2014 (estimated)
- Study startSep 2013
- Primary completionAug 2014 (estimated)
- Study completionSep 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nasopharyngeal CarcinomaStudies of the same condition, open and under way.
- More trials run by Capital Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Songlin Wang, Capital Medical University
- Investigators
- Songlin Wang, Ph.D, Principal investigator, Professor and Vice President of Capital Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02044562
- Sponsor's protocol ID
- 13-07-08
- Status last verified
- Jan 2014
- First submitted
- 21 Jan 2014
- Last updated
- 24 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients Receiving Concurrent Chemo-radiotherapy
- ClinicalTrials.gov ID
- NCT02044562
- Acronym / sponsor ID
- 13-07-08
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- dietary nitrate, radiotherapy, nasopharyngeal carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2014 (estimated)
- Study completion
- Sep 2014 (estimated)
- First posted
- 24 Jan 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate whether dietary nitrate supplementation could improve the plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.
Detailed description
Twenty patients diagnosed as nasopharyngeal carcinoma will be recruited. A 70 ml beetroot juice containing 0.45g nitrate or placebo will be provided to the patients for 7 days at the end of the radiotherapy . The plasma nitrate levels will be determined before radiotherapy, before intervention and after intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| nitrate supplementation | Experimental | Dietary Supplement: nitrate supplementationPatients will receive 7-day nitrate supplementation at the end of the radiotherapy. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients will receive 7-day placebo supplementation at the end of the radiotherapy |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients with newly diagnosed stages III-IVb (UICC 2002) nasopharyngeal carcinomas, will be recruited.
Key exclusion criteria (1 listed)
- Patients with local invasion or metastatic foci in salivary glands, detected by MRI and PET-CT prior to treatment, were excluded, as were patients suffering from diseases, such as Sjogren's syndrome, or with a history of surgery to major salivary glands, or prior head and neck radiotherapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nitrate supplementationA 70 ml beetroot juice containing 0.45g nitrate will be provided to the patients for 7 days at the end of the radiotherapy. | Dietary supplement | nitrate supplementation |
| PlaceboA 70 ml placebo containing 0 g nitrate will be provided to the patients for 7 days at the end of the radiotherapy. | Dietary supplement | Placebo |
Primary outcome
plasma nitrate level
Time frame: one day after nitrate supplementation
The plasma nitrate level will be determined one day after nitrate supplementation.
1 secondary outcome
quality of life
Time frame: one day after nitrate supplementation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Songlin Wang, Ph.D principal investigator
Professor and Vice President of Capital Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing nitrate supplementation in people with Nasopharyngeal Carcinoma, run by Capital Medical University at 1 site 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 1 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 24 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plasma nitrate level (time frame: one day after nitrate supplementation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2014.