NCT01663246

Brief Summary

The investigators are conducting research about oral health and saliva to find out more about the impact of radiation therapy on the oral health of patients. In order to better understand the role of saliva in maintaining oral health in these patients, the investigators will be collecting, storing, and analyzing the quality of saliva, including the protein content, collected from patients following radiation therapy as well as saliva collected from normal healthy adults.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable head-and-neck-cancer

Timeline
Completed

Started Apr 2006

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

April 1, 2006

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2007

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed
3.6 years until next milestone

First Submitted

Initial submission to the registry

July 24, 2012

Completed
20 days until next milestone

First Posted

Study publicly available on registry

August 13, 2012

Completed
Last Updated

August 15, 2014

Status Verified

August 1, 2014

Enrollment Period

1.5 years

First QC Date

July 24, 2012

Last Update Submit

August 14, 2014

Conditions

Head and Neck Cancer

Outcome Measures

Primary Outcomes (2)

  • prevalence of dental caries in patients after PS-IMRT

    Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products

    24 Months

  • prevalence of tooth loss in patients after PS-IMRT

    Various surveys and questionnaires administered for data collection as well as potential risk indicators for dental caries. Oral examination and saliva specimins collected will determine acid, plaque and exposure to tobacco products

    24 months

Secondary Outcomes (1)

  • prevalence of periodontal disease after PS-IMRT

    24 Months

Study Arms (2)

Healthy Adults

ACTIVE COMPARATOR

Healthy adults over the age of 18, with no history of surgery to the salivary glands, or cancer therapy.

Procedure: Saliva Sample

Radiation for Head and Neck Cancer

ACTIVE COMPARATOR

History of radiation therapy for head and neck cancer.

Procedure: Saliva Sample

Interventions

Saliva SamplePROCEDURE

Small plastic cups will be placed on the inside of subject cheeks, and held in place with gentle suction. These cups are attached to tubes which will allow the collection of saliva into a test tube. Saliva will also be collected from the glands underneath the tongue using a small gentle suction device, similar to the one used by a dentist. Saliva production will be stimulated by dabbing a mild citric acid solution that tastes like lemon onto the tongue using a Q-Tip. After this test, subjects will also be asked to chew wax to simulate saliva, and the saliva that accumulates in their mouth will be collected by spitting into a test tube.

Healthy AdultsRadiation for Head and Neck Cancer

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All subjects who have been enrolled in a parotid-sparing IMRT protocol for head and neck cancer at University of Michigan.
  • At least 6 months has elapsed since the completion of RT, at the time of assessment for this study.
  • All subjects must sign a University of Michigan Health System- IRB approved informed consent.
  • Documented Karnofsky performance status \> 60
  • These subjects will all have American Joint Committee on Cancer (AJCC) Stage III or Stage IV disease. (Green et al, 2001) (Appendix 2); non-metastatic, curable disease

You may not qualify if:

  • History of surgical removal of major salivary gland(s).
  • Patients edentulous prior to radiation therapy.
  • Pregnancy or lactation
  • Patients residing in prison.
  • Age\< 18 years.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, 48109-5010, United States

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Avraham Eisbruch, MD

    University of Michigan Rogel Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Newman Family Professor of Radiation Oncology and Professor of Radiation

Study Record Dates

First Submitted

July 24, 2012

First Posted

August 13, 2012

Study Start

April 1, 2006

Primary Completion

October 1, 2007

Study Completion

December 1, 2008

Last Updated

August 15, 2014

Record last verified: 2014-08

Locations

US(1)