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Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients

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ClinicalTrials.gov Identifier: NCT02854410
Recruitment Status : Unknown
Verified July 2016 by Songlin Wang, Capital Medical University.
Recruitment status was:  Not yet recruiting
First Posted : August 3, 2016
Last Update Posted : August 3, 2016
Sponsor:
Collaborators:
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing Friendship Hospital
Information provided by (Responsible Party):
Songlin Wang, Capital Medical University

Brief 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.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Dietary Supplement: Sodium nitrate Dietary Supplement: sodium chloride Not Applicable

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: Dietary Nitrate on Salivary Flow for Nasopharyngeal Carcinoma Patients Pre and Post Concurrent Chemo-radiation Therapy
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Sodium nitrate supplementation
Patients will receive Sodium nitrate supplementation from 7 days before radiotherapy to one month after the end of radiotherapy
Dietary Supplement: Sodium nitrate
Dietary intake:Sodium nitrate 0.5mmol/kgbodyweight,bid

Placebo Comparator: Placebo Comparator(sodium chloride)
Patients will receive placebo from 7 days before radiotherapy to one month after the end of radiotherapy
Dietary Supplement: sodium chloride
Dietary intake:sodium chloride 0.5mmol/kgbodyweight,bid




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with newly diagnosed stages III-IVb (UICC 2002) nasopharyngeal carcinomas, will be recruited.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02854410


Contacts
Contact: Chang Shimin, PHD 13520538923 changsm2005@163.com

Locations
China, Beijing
Capital Medical University School of Stomatology
Beijing, Beijing, China, 100050
Sponsors and Collaborators
Capital Medical University
Cancer Institute and Hospital, Chinese Academy of Medical Sciences
Beijing Friendship Hospital
Investigators
Study Chair: Wang Songlin, PHD Capital Medical University shool of stomatology

Publications:
Responsible Party: Songlin Wang, Professor and Vice President of Capital Medical University, Capital Medical University
ClinicalTrials.gov Identifier: NCT02854410     History of Changes
Other Study ID Numbers: changsm2005
First Posted: August 3, 2016    Key Record Dates
Last Update Posted: August 3, 2016
Last Verified: July 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Songlin Wang, Capital Medical University:
dietary sodium nitrate
radiotherapy
nasopharyngeal carcinoma

Additional relevant MeSH terms:
Carcinoma
Nasopharyngeal Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases