The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in the treatment of osteoradionecrosis (late complication of radiation therapy) of the jaw.
Damage to the lower jaw as a late complication of radiation therapy (osteoradionecrosis (ORN)) is often seen in patients treated with radiation therapy for a tumor in the head and neck region. Part of the lower jaw becomes non-vital and has to be treated. ORN proofs to be a condition difficult to treat and the treatment for this condition varies. In many countries hyperbaric oxygen therapy (HBOT) is added to the surgical treatment of ORN. Unfortunately there is no consensus whether the addition of hyperbaric oxygen therapy to the treatment of ORN is beneficial or not. This study has the aim to investigate the efficacy and cost-effectiveness of HBOT in the treatment of ORN.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
20
30 session inhalation of 100% oxygen in a pressure chamber under 2.4 ATA for 90 minutes a day before surgery and 10 session hyperbaric oxygen therapy (as mentioned before) after surgery
NKI/AvL
Amsterdam, Netherlands
VU University Medical centre
Amsterdam, Netherlands
University Medical Center Groningen
Groningen, Netherlands
Leiden University Medical Center
Leiden, Netherlands
absence of exposed bone, fistulae or ulceration.
Number of patients with complete healing
Time frame: 12 months after finishing therapy in the arm assigned to
Pain score
VAS 0-10 (0 absence of pain, 10 unbearable pain)
Time frame: one year after therapy in the arm assigned to.
Clinical and radiological assessment of the treatment response
Light photography and X-rays to assess the amount of patients without mucosal or bone lesions one year after therapy. The measurements between the start and finish of the inclusion are used to assess increase or decline of the lesions during therapy
Time frame: one year after therapy in the arm assigned to.
Completion of the therapy in the arm for which patient has been randomized; if someone drops out of this study the reason will be scored.
Drop out rate of included patients and scoring of the reason for termination before completing the study.
Time frame: one year after therapy in the arm assigned to.
Use of pain medication
type and quantity
Time frame: one year after therapy in the arm assigned to.
Type of surgical intervention
For each individual patient the type of surgery is scored: sequestrectomy, marginal mandibula resection, segment resection
Time frame: one year after therapy in the arm assigned to.
Quality of life
Quality of life questionnaires EORTC-QoL-C30, Head and Neck-C35. These QoL questionaires are for general QoL for oncology patients (C-30) with a specific part for head and neck oncology (C-35)
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Maastricht Universitary Medical Centre
Maastricht, Netherlands
Radboud University Nijmegen Medical Centre
Nijmegen, Netherlands
Erasmus University Medical Center
Rotterdam, Netherlands
University Medical Center Utrecht
Utrecht, Netherlands
Time frame: one year after therapy in the arm assigned to.
Cost effectiveness
Questionnaire EQ-5D
Time frame: one year after therapy in the arm assigned to.