Clinical trial NCT02057510: Observational Study of Dental Outcomes in Head and Neck Cancer Patients
Official title: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Cancer
Dental Disease
Xerostomia
Osteoradionecrosis
Keywords: Head and Neck Cancer
Radiation Therapy
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Institute of Dental and Craniofacial Research (NIDCR)
name: University of Minnesota
name: UConn Health
name: University of Pennsylvania
name: Brigham and Women's Hospital
name: NYU Langone Health
name: University of North Carolina
First posted: 2014-02-07
Enrollment: 575
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Head and Neck Radiation Oncology patients

Brief summary: 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.

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. Five hundred and seventy-five 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 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 (SCC) or a salivary gland cancer (SGC), and intends to receive external beam radiation therapy (RT) with curative intent (tumor eradication), with or without concomitant chemotherapy;

OR

* Diagnosed with a non-SCC, non-SGC malignancy of the head and neck region, and intends to receive RT, with or without concomitant chemotherapy. The subject must be expected to receive at least 4500 cGy to one of the following sites:

  1. base of tongue
  2. buccal/labial mucosa
  3. epiglottis
  4. floor of mouth
  5. gingiva/alveolar ridge
  6. hard palate
  7. hypopharynx
  8. larynx
  9. lip
  10. mandible
  11. maxilla
  12. maxillary sinus
  13. nasal cavity
  14. nasopharynx
  15. neck
  16. oral cavity
  17. oral tongue
  18. oropharynx
  19. paranasal sinus/orbit
  20. parotid gland
  21. pharynx
  22. retromolar trigone
  23. soft palate
  24. sublingual gland
  25. submandibular gland
  26. tonsil;
* 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.

Primary outcomes:
measure: Tooth loss
timeFrame: Two Years
Secondary outcomes:
measure: Incidence of exposed intraoral bone
timeFrame: Two Years
measure: Extraction complications
timeFrame: Within 14 days following procedure
measure: Decayed, Missing or Filled Surfaces (DMFS) Index
timeFrame: Baseline, 24 months
measure: Periodontal Measures
timeFrame: Baseline, 24 months
measure: Stimulated Salivary Flow Rate
timeFrame: Baseline, 18 months
measure: Trismus measure
timeFrame: Baseline, 24 months
measure: Topical fluoride use for caries prevention
timeFrame: Baseline, 24 months
measure: Chronic Oral Mucositis Incidence
timeFrame: Baseline, 24 months
measure: Quality of Life after Radiation Therapy
timeFrame: Baseline, 24 months
measure: Oral Cancer Pain Scale
timeFrame: Baseline, 24 months
Other outcomes:
Locations:
city: Farmington
country: United States
facility: University of Connecticut Health Center - School of Dental Medicine
state: Connecticut
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: New York
country: United States
facility: New York University - College of Dentistry
state: New York
city: Chapel Hill
country: United States
facility: University of North Carolina - School of Dentistry
state: North Carolina
city: Charlotte
country: United States
facility: Carolinas Medical Center - Dental Clinic
state: North Carolina
city: Philadelphia
country: United States
facility: University of Pennsylvania - School of Dental Medicine
state: Pennsylvania
Study officials:
affiliation: Wake Forest University Health Sciences
name: Michael T Brennan, DDS, MHS
role: STUDY_CHAIR
affiliation: University of Connecticut Health Center - School of Dental Medicine
name: Rajesh Lalla, DDS, PhD
role: STUDY_CHAIR
References:
citation: Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Mohammadi K, Long Simpson L, Voelker H, Hodges JS, Lalla RV. Dental disease before radiotherapy in patients with head and neck cancer: Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients. J Am Dent Assoc. 2017 Dec;148(12):868-877. doi: 10.1016/j.adaj.2017.09.011.
citation: Lalla RV, Treister N, Sollecito T, Schmidt B, Patton LL, Mohammadi K, Hodges JS, Brennan MT; OraRad Study Group. Oral complications at 6 months after radiation therapy for head and neck cancer. Oral Dis. 2017 Nov;23(8):1134-1143. doi: 10.1111/odi.12710. Epub 2017 Aug 3.
citation: Lalla RV, Long-Simpson L, Hodges JS, Treister N, Sollecito T, Schmidt B, Patton LL, Brennan MT; OraRad Study Group. Clinical registry of dental outcomes in head and neck cancer patients (OraRad): rationale, methods, and recruitment considerations. BMC Oral Health. 2017 Feb 27;17(1):59. doi: 10.1186/s12903-017-0344-y.
citation: Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Yang Y, Lin A, Elting LS, Hodges JS, Lalla RV. Epidemiologic factors in patients with advanced head and neck cancer treated with radiation therapy. Head Neck. 2021 Jan;43(1):164-172. doi: 10.1002/hed.26468. Epub 2020 Sep 29.
citation: Talevi V, Wen J, Lalla RV, Brennan MT, Mougeot FB, Mougeot JC. Identification of single nucleotide pleomorphisms associated with periodontal disease in head and neck cancer irradiation patients by exome sequencing. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jul;130(1):32-42.e4. doi: 10.1016/j.oooo.2020.02.013. Epub 2020 May 22.
citation: Mougeot JC, Stevens CB, Almon KG, Paster BJ, Lalla RV, Brennan MT, Mougeot FB. Caries-associated oral microbiome in head and neck cancer radiation patients: a longitudinal study. J Oral Microbiol. 2019 Mar 8;11(1):1586421. doi: 10.1080/20002297.2019.1586421. eCollection 2019.
citation: Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Hodges JS, Lalla RV. Tooth Failure Post-Radiotherapy in Head and Neck Cancer: Primary Report of the Clinical Registry of Dental Outcomes in Head and Neck Cancer Patients (OraRad) Study. Int J Radiat Oncol Biol Phys. 2022 Jun 1;113(2):320-330. doi: 10.1016/j.ijrobp.2021.11.021. Epub 2021 Dec 5.
citation: Lalla RV, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Helgeson ES, Lin A, Rybczyk C, Dowsett R, Hegde U, Boyd TS, Duplinsky TG, Brennan MT. Radiation therapy for head and neck cancer leads to gingival recession associated with dental caries. Oral Surg Oral Med Oral Pathol Oral Radiol. 2022 May;133(5):539-546. doi: 10.1016/j.oooo.2022.01.016. Epub 2022 Jan 31.
citation: Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Elting LS, Helgeson ES, Lalla RV. Dental Caries Postradiotherapy in Head and Neck Cancer. JDR Clin Trans Res. 2023 Jul;8(3):234-243. doi: 10.1177/23800844221086563. Epub 2022 Apr 11.
citation: Lin A, Helgeson ES, Treister NS, Schmidt BL, Patton LL, Elting LS, Lalla RV, Brennan MT, Sollecito TP. The impact of head and neck radiotherapy on salivary flow and quality of life: Results of the ORARAD study. Oral Oncol. 2022 Apr;127:105783. doi: 10.1016/j.oraloncology.2022.105783. Epub 2022 Feb 26.
citation: Treister NS, Brennan MT, Sollecito TP, Schmidt BL, Patton LL, Mitchell R, Haddad RI, Tishler RB, Lin A, Shadick R, Hodges JS, Lalla RV. Exposed bone in patients with head and neck cancer treated with radiation therapy: An analysis of the Observational Study of Dental Outcomes in Head and Neck Cancer Patients (OraRad). Cancer. 2022 Feb 1;128(3):487-496. doi: 10.1002/cncr.33948. Epub 2021 Oct 19.
citation: Ward MC, Carpenter MD, Noll J, Carrizosa D, Moeller BJ, Helgeson ES, Lalla RV, Brennan MT. Oncologists' Perspective on Dental Care Around the Treatment of Head and Neck Cancer: A Pattern of Practice Survey. JCO Oncol Pract. 2022 Jan;18(1):e28-e35. doi: 10.1200/OP.20.00913. Epub 2021 Jul 9.
citation: Threet EJ, Napenas JJ, Petersen C, Mitchell R, Long-Simpson L, Shadick R, Valentino KC, Rybczyk CA, Blake JA, Brown MC, Aidoo R, Helgeson ES, Lalla RV, Brennan MT. Survey of experiences and barriers to dental care post-head and neck cancer in OraRad study participants. Oral Surg Oral Med Oral Pathol Oral Radiol. 2023 Apr;135(4):501-509. doi: 10.1016/j.oooo.2022.11.011. Epub 2022 Dec 13.
citation: Lalla RV, Hodges JS, Treister NS, Sollecito TP, Schmidt BL, Patton LL, Lin A, Brennan MT. Tooth-level predictors of tooth loss and exposed bone after radiation therapy for head and neck cancer. J Am Dent Assoc. 2023 Jun;154(6):519-528.e4. doi: 10.1016/j.adaj.2023.03.009.
citation: Patton LL, Helgeson ES, Brennan MT, Treister NS, Sollecito TP, Schmidt BL, Lin A, Chera BS, Lalla RV. Oral health-related quality of life after radiation therapy for head and neck cancer: the OraRad study. Support Care Cancer. 2023 Apr 20;31(5):286. doi: 10.1007/s00520-023-07750-2.