Nasopharyngeal CarcinomaNCT02854410
Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients
A study testing Sodium nitrate and sodium chloride 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 salivary flow for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Nasopharyngeal Carcinoma
- What is being tested?
- Sodium nitrate and sodium chloride
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Aug 2016to Dec 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older 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 positron emission computed tomography(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
Capital Medical University School of Stomatology
Beijing, Beijing Municipality, 100050
About this study
Official title: Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients Pre and Post Concurrent Chemo-radiation Therapy
The purpose of this study is to evaluate whether dietary nitrate supplementation could improve the salivary flow for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.
Read the detailed description
Thirty patients diagnosed as nasopharyngeal carcinoma will be recruited. Nitrate supplement(Sodium nitrate: 0.5 mmol/kgbodyweight,bid) or placebo(sodium chloride: 0.5 mmol/kgbodyweight,bid) will be provided to the patients from 7 days before radiotherapy to one month after the finish of radiotherapy . The salivary flow and plasma nitrate levels will be determined before the course of nitrate supplementation and radiotherapy,before the course of radiotherapy,post the course of radiotherapy immediately and one month after the finish of radiotherapy.
- Conditions
- Nasopharyngeal Carcinoma
- Being tested
- Sodium nitrate, sodium chloride
- Keywords
- dietary sodium 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.
Sodium nitrateDietary supplement
Dietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid
sodium chlorideDietary supplement
Dietary intake:sodium chloride 0.5mmol/kgbodyweight,bid
| Study group | Role | What they receive |
|---|---|---|
| Sodium nitrate supplementation | Experimental | Patients will receive Sodium nitrate supplementation from 7 days before radiotherapy to one month after the end of radiotherapy Receives: Dietary Supplement: Sodium nitrate |
| Placebo Comparator(sodium chloride) | Placebo comparator | Patients will receive placebo from 7 days before radiotherapy to one month after the end of radiotherapy Receives: Dietary Supplement: sodium chloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of salivary flow
Measured: one day before the course of nitrate supplementation and radiotherapy,one day before the course of radiotherapy,one day post the course of radiotherapy and one month after the finish of radiotherapy
Secondary outcomes (1)
Chang of plasm nitrate level
Measured: one day before the course of nitrate supplementation and radiotherapy,one day before the course of radiotherapy,one day post the course of radiotherapy and one month after the finish of radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2016 (estimated)
- Study startAug 2016
- Primary completionAug 2018 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Capital Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Friendship Hospital
- Responsible party
- Principal investigator, Songlin Wang, Capital Medical University
- Investigators
- Wang Songlin, PHD, Study chair, Capital Medical University shool of stomatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02854410
- Sponsor's protocol ID
- changsm2005
- Status last verified
- Jul 2016
- First submitted
- 23 Jul 2016
- Last updated
- 3 Aug 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Xia DS, Deng DJ, Wang SL. Destruction of parotid glands affects nitrate and nitrite metabolism. J Dent Res. 2003 Feb;82(2):101-5. doi: 10.1177/154405910308200205.
PubMed 12562881Xia DS, Liu Y, Zhang CM, Yang SH, Wang SL. Antimicrobial effect of acidified nitrate and nitrite on six common oral pathogens in vitro. Chin Med J (Engl). 2006 Nov 20;119(22):1904-9.
PubMed 17134590Xia D, Deng D, Wang S. Alterations of nitrate and nitrite content in saliva, serum, and urine in patients with salivary dysfunction. J Oral Pathol Med. 2003 Feb;32(2):95-9. doi: 10.1034/j.1600-0714.2003.00109.x.
PubMed 12542832Bryan NS, Ivy JL. Inorganic nitrite and nitrate: evidence to support consideration as dietary nutrients. Nutr Res. 2015 Aug;35(8):643-54. doi: 10.1016/j.nutres.2015.06.001. Epub 2015 Jun 11.
PubMed 26189149Xia D, Qu X, Tran SD, Schmidt LL, Qin L, Zhang C, Cui X, Deng D, Wang S. Histological characteristics following a long-term nitrate-rich diet in miniature pigs with parotid atrophy. Int J Clin Exp Pathol. 2015 Jun 1;8(6):6225-34. eCollection 2015.
PubMed 26261499
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients Pre and Post Concurrent Chemo-radiation Therapy
- ClinicalTrials.gov ID
- NCT02854410
- Acronym / sponsor ID
- changsm2005
- Conditions
- Nasopharyngeal Carcinoma
- Keywords
- dietary sodium nitrate, radiotherapy, nasopharyngeal carcinoma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Capital Medical UniversityUniversity, hospital or other
- Collaborators
- Cancer Institute and Hospital, Chinese Academy of Medical Sciences, Beijing Friendship Hospital
- Study start
- Aug 2016
- Primary completion
- Aug 2018 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 3 Aug 2016 (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 salivary flow for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.
Detailed description
Thirty patients diagnosed as nasopharyngeal carcinoma will be recruited. Nitrate supplement(Sodium nitrate: 0.5 mmol/kgbodyweight,bid) or placebo(sodium chloride: 0.5 mmol/kgbodyweight,bid) will be provided to the patients from 7 days before radiotherapy to one month after the finish of radiotherapy . The salivary flow and plasma nitrate levels will be determined before the course of nitrate supplementation and radiotherapy,before the course of radiotherapy,post the course of radiotherapy immediately and one month after the finish of radiotherapy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium nitrate supplementation | Experimental | Dietary Supplement: Sodium nitratePatients will receive Sodium nitrate supplementation from 7 days before radiotherapy to one month after the end of radiotherapy |
| Placebo Comparator(sodium chloride) | Placebo comparator | Dietary Supplement: sodium chloridePatients will receive placebo from 7 days before radiotherapy to one month after the end of radiotherapy |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older 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 positron emission computed tomography(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 |
|---|---|---|
| Sodium nitrateDietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid | Dietary supplement | Sodium nitrate supplementation |
| sodium chlorideDietary intake:sodium chloride 0.5mmol/kgbodyweight,bid | Dietary supplement | Placebo Comparator(sodium chloride) |
Primary outcome
Change of salivary flow
Time frame: one day before the course of nitrate supplementation and radiotherapy,one day before the course of radiotherapy,one day post the course of radiotherapy and one month after the finish of radiotherapy
1 secondary outcome
Chang of plasm nitrate level
Time frame: one day before the course of nitrate supplementation and radiotherapy,one day before the course of radiotherapy,one day post the course of radiotherapy and one month after the finish of radiotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2016.
- Background: PubMed 12562881Xia DS, Deng DJ, Wang SL. Destruction of parotid glands affects nitrate and nitrite metabolism. J Dent Res. 2003 Feb;82(2):101-5. doi: 10.1177/154405910308200205.
- Background: PubMed 17134590Xia DS, Liu Y, Zhang CM, Yang SH, Wang SL. Antimicrobial effect of acidified nitrate and nitrite on six common oral pathogens in vitro. Chin Med J (Engl). 2006 Nov 20;119(22):1904-9.
- Background: PubMed 12542832Xia D, Deng D, Wang S. Alterations of nitrate and nitrite content in saliva, serum, and urine in patients with salivary dysfunction. J Oral Pathol Med. 2003 Feb;32(2):95-9. doi: 10.1034/j.1600-0714.2003.00109.x.
- Background: PubMed 26189149Bryan NS, Ivy JL. Inorganic nitrite and nitrate: evidence to support consideration as dietary nutrients. Nutr Res. 2015 Aug;35(8):643-54. doi: 10.1016/j.nutres.2015.06.001. Epub 2015 Jun 11.
- Background: PubMed 26261499Xia D, Qu X, Tran SD, Schmidt LL, Qin L, Zhang C, Cui X, Deng D, Wang S. Histological characteristics following a long-term nitrate-rich diet in miniature pigs with parotid atrophy. Int J Clin Exp Pathol. 2015 Jun 1;8(6):6225-34. eCollection 2015.
- Individual participant dataSharing planned: Undecided
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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.
Wang Songlin, PHD study chair
Capital Medical University shool of stomatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sodium nitrate and sodium chloride 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 3 Aug 2016. 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?
Contact Chang Shimin, PHD (13520538923, changsm2005@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of salivary flow (time frame: one day before the course of nitrate supplementation and radiotherapy,one day before the course of radiotherapy,one day post the course of radiotherapy and one month after the finish of radiotherapy). 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 NCT02854410, which also lists 5 linked publications.
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 3 Aug 2016.