Osteoradionecrosis
Conditions
Keywords
osteoradionecrosis, mandible, radiotherapy, hyperbaric oxygen therapy
Brief summary
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.
Detailed description
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.
Interventions
DRUGhyperbaric oxygen
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
Sponsors
Radboud University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Informed consent * Age ≥ 18 jr * WHO performance status 0-2 * Last radiation treatment ≥ 6 month ago radiotherapy with curative intention and \> 55 Gy. The affected part of the jaw must be in the target volume area of the radiotherapy field. * Local recurrence must be ruled out * Necrosis of the jaw with at least one of the following symptoms for over 3 month present: * Bone exposition which measures at least 1 cm * Evident bone lesions at radiologic evaluation (panorex) that fits the diagnosis ORN. * Non-healing extraction socket
Exclusion criteria
* Former HBO treatment * Contra indication for HBO treatment (pneumothorax) * Bisphosphonate treatment in the medical history * reirradiation in the medical history * Osteosynthesis material in the affected area * Distant metastasis * Primary or recurrent tumor in the affected area * Malignancies elsewhere
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| absence of exposed bone, fistulae or ulceration. | 12 months after finishing therapy in the arm assigned to | Number of patients with complete healing |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Clinical and radiological assessment of the treatment response | one year after therapy in the arm assigned to. | 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 |
| 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. | one year after therapy in the arm assigned to. | Drop out rate of included patients and scoring of the reason for termination before completing the study. |
| Use of pain medication | one year after therapy in the arm assigned to. | type and quantity |
| Pain score | one year after therapy in the arm assigned to. | VAS 0-10 (0 absence of pain, 10 unbearable pain) |
| Quality of life | one year after therapy in the arm assigned to. | 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) |
| Cost effectiveness | one year after therapy in the arm assigned to. | Questionnaire EQ-5D |
| Type of surgical intervention | one year after therapy in the arm assigned to. | For each individual patient the type of surgery is scored: sequestrectomy, marginal mandibula resection, segment resection |
Countries
Netherlands
Outcome results
None listed