Observational Study of Dental Outcomes in Head and Neck Cancer Patients (ORARAD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Carolinas Healthcare System
Sponsor:
Collaborators:
University of Minnesota - Clinical and Translational Science Institute
University of Connecticut Health Center
University of Pennsylvania
Brigham and Women's Hospital
New York University School of Medicine
Information provided by (Responsible Party):
Michael T. Brennan, Carolinas Healthcare System
ClinicalTrials.gov Identifier:
NCT02057510
First received: February 5, 2014
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

The purpose of this study is to measure the two-year rate of tooth loss in patients who have received external beam radiation therapy with curative intent for head and neck cancer. The study will also evaluate the sequelae of radiation therapy and oral complications that may occur as a result to receiving radiation therapy.


Condition
Head and Neck Cancer
Dental Disease
Xerostomia
Osteoradionecrosis

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 24 Months
Official Title: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients

Resource links provided by NLM:


Further study details as provided by Carolinas Healthcare System:

Primary Outcome Measures:
  • Tooth loss [ Time Frame: Two Years ] [ Designated as safety issue: No ]

    The primary outcome measure is the two-year rate of tooth loss in patients who have received at least one session of external beam radiation therapy with curative intent for head and neck cancer.

    "Tooth loss" will be defined as a dental extraction that has been performed or recommended. Since dental extractions are often avoided in this population because of the increased risk of osteoradionecrosis (ORN), tooth loss will also include teeth having a dental procedure to avoid extraction of a tooth that would otherwise have been extracted if the individual had not received RT and teeth recommended for extraction that have not been treated. The following categories will constitute teeth that would otherwise be recommended for extraction:

    • non-restorable because of fracture or extent of caries;
    • amputated crown with root remaining;
    • uncontrolled or persistent periodontal or odontogenic infection.


Secondary Outcome Measures:
  • Incidence of exposed intraoral bone [ Time Frame: Two Years ] [ Designated as safety issue: No ]
    Two year incidence of exposed intraoral bone, suggestive of ORN. This will be defined as exposed maxillary or mandibular bone with an avascular appearance in a quadrant that has received RT

  • Extraction complications [ Time Frame: Within 14 days following procedure ] [ Designated as safety issue: No ]
    Incidence of post-extraction complications

  • Decayed, Missing or Filled Surfaces (DMFS) Index [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Two year change in DMFS - Decayed, Missing or Filled Surfaces Index

  • Periodontal Measures [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Two year change in periodontal measures

  • Stimulated Salivary Flow Rate [ Time Frame: Baseline, 18 months ] [ Designated as safety issue: No ]
    18 month changes in stimulated whole salivary flow rates

  • Trismus measure [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Two year change in mouth opening in mm

  • Topical fluoride use for caries prevention [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Two year use of fluoride to prevent new caries

  • Chronic Oral Mucositis Incidence [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Two year chronic oral mucositis incidence

  • Quality of Life after Radiation Therapy [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Two year change in radiation therapy-specific quality of life measures

  • Oral Cancer Pain Scale [ Time Frame: Baseline, 24 months ] [ Designated as safety issue: No ]
    Two year change in pain scores as measured with the University of California at San Francisco (UCSF) oral cancer pain scale


Estimated Enrollment: 756
Study Start Date: February 2014
Estimated Study Completion Date: May 2017
Estimated Primary Completion Date: May 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Head and Neck Cancer patients receiving radiation therapy
No intervention

Detailed Description:

This is a prospective cohort study to document dental and other oral outcomes in patients who receive external beam radiation therapy with curative intent, as part of clinical care for a head and neck cancer. Seven hundred and fifty-six participants will be enrolled. All study participants will receive a baseline oral examination prior to the start of radiation therapy. Follow-up examinations and data collection will be conducted at six-month intervals up to 2 years after the start of radiation therapy. The primary outcome will be the two-year rate of tooth loss. Secondary outcomes will include measures of dental caries, periodontal health, salivary flow, and exposed bone/osteoradionecrosis.

The proposed research will provide more information to inform the community about the sequelae of Radiation Therapy (RT) in head and neck cancer patients, to refine current guidelines and to design future studies on the dental management of these patients.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Head and Neck Radiation Oncology patients

Criteria

Inclusion Criteria:

  • Aged 18 years and older;
  • Willing and able to provide signed and dated consent form;
  • Diagnosed with head and neck squamous cell carcinoma or a salivary gland cancer;
  • Intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;
  • At least 1 natural tooth remaining or expected to remain in the mouth after completion of the pre-RT dental extractions, if any;
  • Willing to comply with all study procedures;
  • Willing to participate for the duration of the study.

Exclusion Criteria:

  • Receiving palliative RT;
  • History of prior curative RT to the head and neck region to eradicate a malignancy;
  • Incarcerated at time of screening;
  • Anything that would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02057510

Locations
United States, Connecticut
University of Connecticut Health Center - School of Dental Medicine Recruiting
Farmington, Connecticut, United States, 06030
Contact: Linda Choquette, RDH, MSHS    860-679-3918    choquette@uchc.edu   
Principal Investigator: Rajesh Lalla, DDS, PhD         
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02120
Contact: Jennifer Brewer    617-732-6813    jbrewer6@partners.org   
Principal Investigator: Nathaniel Treister, DMD         
United States, New York
New York University - College of Dentistry Recruiting
New York, New York, United States, 10010
Contact: Dinah Neri, MD    212-998-9202    ddn1@nyu.edu   
Principal Investigator: Brian Schmidt, DDS, MD, PhD         
United States, North Carolina
Carolinas Medical Center - Dental Clinic Recruiting
Charlotte, North Carolina, United States, 28203
Contact: Maggie Tanner, RN, RDH    704-355-0174    maggie.tanner@carolinashealthcare.org   
Principal Investigator: Michael Brennan, DDS, MHS         
United States, Pennsylvania
University of Pennsylvania - School of Dental Medicine Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Dan Vernau    215-349-5409    vernaud@mail.med.upenn.edu   
Principal Investigator: Thomas Sollecito, DDS         
Sponsors and Collaborators
Carolinas Healthcare System
University of Minnesota - Clinical and Translational Science Institute
University of Connecticut Health Center
University of Pennsylvania
Brigham and Women's Hospital
New York University School of Medicine
Investigators
Study Chair: Michael T Brennan, DDS, MHS Carolinas Healthcare System
Study Chair: Rajesh Lalla, DDs, PhD University of Connecticut Health Center - School of Dental Medicine
  More Information

No publications provided

Responsible Party: Michael T. Brennan, Michael Brennan, DDS, MHS, Carolinas Healthcare System
ClinicalTrials.gov Identifier: NCT02057510     History of Changes
Other Study ID Numbers: 12-040-E, 1U01DE022939-01
Study First Received: February 5, 2014
Last Updated: April 23, 2014
Health Authority: United States: Data and Safety Monitoring Board

Keywords provided by Carolinas Healthcare System:
Head and Neck Cancer
Radiation Therapy

Additional relevant MeSH terms:
Tooth Diseases
Head and Neck Neoplasms
Xerostomia
Osteoradionecrosis
Neoplasms by Site
Neoplasms
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Radiation Injuries
Wounds and Injuries

ClinicalTrials.gov processed this record on September 22, 2014