Clinical trial NCT04009161: Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment.
Official title: Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment: a Perspective Clinical Study.
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Head and Neck Cancer
Osteoradionecrosis
Radiotherapy Side Effect
Tooth Avulsion
Lead sponsor: Catholic University of the Sacred Heart
Sponsor class: OTHER
First posted: 2019-07-05
Enrollment: 160
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients irradiated for head and neck cancer

Brief summary: Objectives High-dose radiotherapy (RT) for head and neck cancer has significant adverse effects on maxillofacial tissues, among which osteoradionecrosis (ORN) is the most severe and potentially life-threatening. Although tooth extractions seem to be the main risk factor, few perspective studies evaluated protocols to minimize the ORN risk due to extractions. The aim of this study is to evaluate incidence and risk factors of ORN in a cohort of patients receiving tooth extractions before RT and evaluate an algorithm about extraction decision.

Methods One-hundred ten patients were consecutively recruited in this study: impacted third molars with radiographic sign of pericoronitis, teeth with periapical lesions, unrestorable teeth, periodontally compromised teeth (pocket probing depth \>5 mm, clinical attachment loss \> 8 mm, grade 2 tooth mobility, II grade furcation involvement) were extracted under antibiotic prophylaxis. A 15-days interval between the last tooth extraction and the beginning of RT was recommended. Patients were visited at 15 days, 1, 3 and 6 months after the beginning of RT. Data of patients with a minimum of 6 months follow-up are presented in this report. ORN was defined as irradiated exposed necrotic bone, without healing for 3 months, in absence of cancer recurrence. The protocol was approved by the Ethic Committee of Catholic University - Fondazione Policlinico Gemelli (Prot. OHHN-1, ID-2132).


Eligibility criteria: Inclusion Criteria:

* Patients willing to sign the informed consent form
* Patients with diagnosis of HNC, with specific prescription of local radiotherapy, both for curative and palliative purpose, with or without chemotherapic treatment.
* Patient with diagnosis of HNC, with specific prescription of local radiotherapy as an adjuvant to surgical resection, with or without chemotherapic treatment.

Exclusion Criteria:

* Patients participating to other clinical studies
* Patients who refuse to participate in the study
* Patients unable to attend the ambulatory visits scheduled by the protocol

Primary outcomes:
measure: Osteoradionecrosis Incidence
timeFrame: 60 months after the beginning of RT
measure: Osteoradionecrosis rate following pre-radiotherapy tooth extraction
timeFrame: 60 months after the beginning of RT
Secondary outcomes:
measure: Extraction site: number of tooth extractions for each site (anterior and posterior maxilla or mandible and specific tooth number) and percentage of ORN for each site.
timeFrame: 60 months after the beginning of RT
measure: Time interval between extraction and Radiotherapy: days between every tooth extraction and the beginning of RT.
timeFrame: 60 months after the beginning of RT
measure: Surgical protocol 1: Flap elevation per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure.
timeFrame: 60 months after the beginning of RT
measure: Surgical protocol 2: Primary intention closure achievement per post-extractive site (YES/NO) and percentage of ORN per each type of procedure.
timeFrame: 60 months after the beginning of RT
measure: Surgical protocol 3: Osteotomy per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure.
timeFrame: 60 months after the beginning of RT
measure: Reason for tooth extraction: number of tooth extraction for each cause under the protocol (caries, periodontal disease, endodontic lesions, pericoronitis, fracture) and percentage of ORN for each cause.
timeFrame: 60 months after the beginning of RT
measure: Radiation dose to the post-extractive site (Gy of radiation received by every post-extractive site)
timeFrame: 60 months after the beginning of RT
measure: Age of every patients at the beginning of RT
timeFrame: At baseline
measure: Sex (male, female) of every patients at the beginning of RT
timeFrame: At baseline
measure: Number of participants undergoing concurrent chemotherapy (neoadjuvant or concomitant)
timeFrame: During treatment
Other outcomes:
Locations:
city: Rome
country: Italy
facility: Catholic University of the Sacred Heart
Study officials:
References:
citation: Rupe C, Gioco G, Almadori G, Galli J, Micciche F, Olivieri M, Cordaro M, Lajolo C. Oral Candida spp. Colonisation Is a Risk Factor for Severe Oral Mucositis in Patients Undergoing Radiotherapy for Head & Neck Cancer: Results from a Multidisciplinary Mono-Institutional Prospective Observational Study. Cancers (Basel). 2022 Sep 29;14(19):4746. doi: 10.3390/cancers14194746.