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Trial record 31 of 705 for:    dry mouth

Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation (NRR)

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ClinicalTrials.gov Identifier: NCT02682199
Recruitment Status : Completed
First Posted : February 15, 2016
Last Update Posted : August 31, 2018
Sponsor:
Information provided by (Responsible Party):
UNC Lineberger Comprehensive Cancer Center

Tracking Information
First Submitted Date January 20, 2016
First Posted Date February 15, 2016
Last Update Posted Date August 31, 2018
Actual Study Start Date October 2015
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 12, 2016)
Measureable acute increase in xerostomia [ Time Frame: baseline to 1 month post-treatment ]
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT02682199 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 13, 2017)
  • Association of degree of change in xerostomia score and the radiation dose received by the parotid glands [ Time Frame: baseline to 1 month post-RT ]
  • Effect of whole brain radiation on the time course of xerostomia [ Time Frame: baseline and four post-radiation time points (procedure, 1 month post-RT, 3 months post-RT, 6 months post-RT). ]
Original Secondary Outcome Measures
 (submitted: February 12, 2016)
  • Association of degree of change in xerostomia score and the radiation dose received by the parotid glands [ Time Frame: baseline to 1 month post-RT ]
  • Effect of whole brain radiation on the time course of xerosomia [ Time Frame: baseline and four post-radiation time points (procedure, 1 month post-RT, 3 months post-RT, 6 months post-RT). ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation
Official Title Prospective Evaluation of Patient-Reported Xerostomia After Whole Brain Radiation
Brief Summary The goal of this prospective observational study is to investigate whether whole brain radiation leads to measurable xerostomia from parotid gland toxicity.
Detailed Description The parotids have not been traditionally considered an organ at risk / avoidance structure in whole brain radiation. However, patients receiving whole brain radiation sometimes complain of dry mouth. Investigators hypothesize that standard whole brain radiation fields cause an acute measurable increase in xerostomia at one month post-radiation, and that the severity of xerostomia is related to the dose received by the parotids. In this study, investigators will use the validated University of Michigan Xerostomia Questionnaire to prospectively collect baseline and post-radiation xerostomia scores up to 6 months after treatment. The radiation dose to the parotids will be evaluated to assess whether there is a dose-toxicity relationship. Investigators anticipate a total accrual of 60 patients with a goal of 48 evaluable patients.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients undergoing whole brain radiation treatment at Lineberger Comprehensive cancer Center.
Condition Xerostomia
Intervention Not Provided
Study Groups/Cohorts Whole Brain Radiation
Patients scheduled to receive whole brain radiation with or without chemotherapy/targeted therapy.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 30, 2018)
100
Original Estimated Enrollment
 (submitted: February 12, 2016)
60
Actual Study Completion Date August 30, 2018
Actual Primary Completion Date May 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Patients to be treated with whole brain radiation in 10-15 fractions to a total dose of 25-37.5 Gy for a diagnosis of brain metastases from any disease site or as prophylaxis in the treatment of potentially subclinical intracranial disease (e.g. from small cell lung cancer).
  • Has not had prior radiation that would have exposed the parotids to a significant (estimated >10 Gy mean parotid dose) level of radiation within the past one year. Patients receiving prior stereotactic radiosurgery for brain metastasis are eligible for inclusion in this trial as this form of radiation is highly conformal and exposes the parotids to minimal (estimated <1 Gy) radiation.
  • Greater than or equal to 18 years of age (no upper age limit).
  • Informed consent obtained.

Exclusion Criteria:

  • Patients receiving whole brain radiation without the use of a CT-based planning simulation.
  • Patients who are on medications known to cause dry mouth, such as anticholinergics.
  • Physically unable to communicate by paper or phone to complete the study survey.
  • Prisoners.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02682199
Other Study ID Numbers LCCC1540
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party UNC Lineberger Comprehensive Cancer Center
Study Sponsor UNC Lineberger Comprehensive Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Kyle Wang, MD University of North Carolina, Chapel Hill
PRS Account UNC Lineberger Comprehensive Cancer Center
Verification Date August 2018