NCT02682199

Brief Summary

The goal of this prospective observational study is to investigate whether whole brain radiation leads to measurable xerostomia from parotid gland toxicity.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Oct 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2015

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

January 20, 2016

Completed
26 days until next milestone

First Posted

Study publicly available on registry

February 15, 2016

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2018

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2018

Completed
Last Updated

September 23, 2019

Status Verified

September 1, 2019

Enrollment Period

2.6 years

First QC Date

January 20, 2016

Last Update Submit

September 19, 2019

Conditions

Xerostomia

Outcome Measures

Primary Outcomes (1)

  • Measureable acute increase in xerostomia

    baseline to 1 month post-treatment

Secondary Outcomes (2)

  • Association of degree of change in xerostomia score and the radiation dose received by the parotid glands

    baseline to 1 month post-RT

  • Effect of whole brain radiation on the time course of xerostomia

    baseline and four post-radiation time points (procedure, 1 month post-RT, 3 months post-RT, 6 months post-RT).

Study Arms (1)

Whole Brain Radiation

Patients scheduled to receive whole brain radiation with or without chemotherapy/targeted therapy.

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing whole brain radiation treatment at Lineberger Comprehensive cancer Center.

You may qualify if:

  • 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).
  • Greater than or equal to 18 years of age (no upper age limit).
  • Informed consent obtained.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of North Carolina at Chapel Hill, Department of Radiation Oncology

Chapel Hill, North Carolina, 27599, United States

Location

Related Links

MeSH Terms

Conditions

Xerostomia

Condition Hierarchy (Ancestors)

Salivary Gland DiseasesMouth DiseasesStomatognathic Diseases

Study Officials

  • Kyle Wang, MD

    University of North Carolina, Chapel Hill

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 20, 2016

First Posted

February 15, 2016

Study Start

October 1, 2015

Primary Completion

May 1, 2018

Study Completion

August 30, 2018

Last Updated

September 23, 2019

Record last verified: 2019-09

Locations

US(1)