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Trial record 4 of 528 for:    NITRATE ION

Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients

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ClinicalTrials.gov Identifier: NCT02044562
Recruitment Status : Unknown
Verified January 2014 by Songlin Wang, Capital Medical University.
Recruitment status was:  Recruiting
First Posted : January 24, 2014
Last Update Posted : January 24, 2014
Sponsor:
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 plasma nitrate levels for nasopharyngeal carcinoma patients receiving concurrent chemo-radiation therapy.

Condition or disease Intervention/treatment Phase
Nasopharyngeal Carcinoma Dietary Supplement: nitrate supplementation Dietary Supplement: Placebo Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients Receiving Concurrent Chemo-radiotherapy
Study Start Date : September 2013
Estimated Primary Completion Date : August 2014
Estimated Study Completion Date : September 2014

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Arm Intervention/treatment
Experimental: nitrate supplementation
Patients will receive 7-day nitrate supplementation at the end of the radiotherapy.
Dietary Supplement: nitrate supplementation
A 70 ml beetroot juice containing 0.45g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.

Placebo Comparator: Placebo
Patients will receive 7-day placebo supplementation at the end of the radiotherapy
Dietary Supplement: Placebo
A 70 ml placebo containing 0 g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.




Primary Outcome Measures :
  1. plasma nitrate level [ Time Frame: one day after nitrate supplementation ]
    The plasma nitrate level will be determined one day after nitrate supplementation.


Secondary Outcome Measures :
  1. quality of life [ Time Frame: one day after nitrate supplementation ]
    The quality of life will be assessed one day after nitrate supplementation.



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Ages Eligible for Study:   20 Years to 60 Years   (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 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): NCT02044562


Locations
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China, Beijing
Capital Medical University School of Stomatology Recruiting
Beijing, Beijing, China, 100050
Contact: Xingmin Qu    8610-57099421    xingminqu@sina.com   
Sponsors and Collaborators
Capital Medical University
Investigators
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Principal Investigator: Songlin Wang, Ph.D Professor and Vice President of Capital Medical University

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Responsible Party: Songlin Wang, Professor and Vice President, Capital Medical University
ClinicalTrials.gov Identifier: NCT02044562     History of Changes
Other Study ID Numbers: 13-07-08
First Posted: January 24, 2014    Key Record Dates
Last Update Posted: January 24, 2014
Last Verified: January 2014
Keywords provided by Songlin Wang, Capital Medical University:
dietary nitrate
radiotherapy
nasopharyngeal carcinoma
Additional relevant MeSH terms:
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Carcinoma
Nasopharyngeal Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Nasopharyngeal Neoplasms
Pharyngeal Neoplasms
Otorhinolaryngologic Neoplasms
Head and Neck Neoplasms
Neoplasms by Site
Nasopharyngeal Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Otorhinolaryngologic Diseases