Back to resultsDietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients
Primary Purpose
Nasopharyngeal Carcinoma
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
nitrate supplementation
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Nasopharyngeal Carcinoma focused on measuring dietary nitrate, radiotherapy, nasopharyngeal carcinoma
Eligibility 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.
Sites / Locations
- Capital Medical University School of StomatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
nitrate supplementation
Placebo
Arm Description
Patients will receive 7-day nitrate supplementation at the end of the radiotherapy.
Patients will receive 7-day placebo supplementation at the end of the radiotherapy
Outcomes
Primary Outcome Measures
plasma nitrate level
The plasma nitrate level will be determined one day after nitrate supplementation.
Secondary Outcome Measures
quality of life
The quality of life will be assessed one day after nitrate supplementation.
Full Information
NCT ID
NCT02044562
First Posted
January 21, 2014
Last Updated
January 22, 2014
Sponsor
Capital Medical University
1. Study Identification
Unique Protocol Identification Number
NCT02044562
Brief Title
Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients
Official Title
Study of Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients Receiving Concurrent Chemo-radiotherapy
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Unknown status
Study Start Date
September 2013 (undefined)
Primary Completion Date
August 2014 (Anticipated)
Study Completion Date
September 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Capital Medical University
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Nasopharyngeal Carcinoma
Keywords
dietary nitrate, radiotherapy, nasopharyngeal carcinoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
nitrate supplementation
Arm Type
Experimental
Arm Description
Patients will receive 7-day nitrate supplementation at the end of the radiotherapy.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Patients will receive 7-day placebo supplementation at the end of the radiotherapy
Intervention Type
Dietary Supplement
Intervention Name(s)
nitrate supplementation
Intervention Description
A 70 ml beetroot juice containing 0.45g nitrate will be provided to the patients for 7 days at the end of the radiotherapy.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
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 Measure Information:
Title
plasma nitrate level
Description
The plasma nitrate level will be determined one day after nitrate supplementation.
Time Frame
one day after nitrate supplementation
Secondary Outcome Measure Information:
Title
quality of life
Description
The quality of life will be assessed one day after nitrate supplementation.
Time Frame
one day after nitrate supplementation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Songlin Wang, Ph.D
Organizational Affiliation
Professor and Vice President of Capital Medical University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Capital Medical University School of Stomatology
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100050
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xingmin Qu
Phone
8610-57099421
Email
xingminqu@sina.com
12. IPD Sharing Statement
Learn more about this trial
Dietary Nitrate on Plasma Nitrate Levels for Nasopharyngeal Carcinoma Patients
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