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Recruitment problems, patients refused to participate
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Surgery | No Intervention | This is the standard arm. Surgery without hyperbaric oxygen treatment | |
| Hyperbaric oxygen therapy with surgery | Experimental | Intervention arm. Hyperbaric oxygen therapy with surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hyperbaric oxygen | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| absence of exposed bone, fistulae or ulceration. | Number of patients with complete healing | 12 months after finishing therapy in the arm assigned to |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score | VAS 0-10 (0 absence of pain, 10 unbearable pain) | 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 |
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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:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Francois Dieleman, MD DMD | Radboud University Medical Center | Principal Investigator |
| Thijs Merkx, MD DMD PhD | Radboud University Medical Center | Study Director |
| Hans Kaanders, MD PhD | Raboud University Medical Centre | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| NKI/AvL | Amsterdam | 1066CX | Netherlands | |||
| VU University Medical centre |
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| Label | URL |
|---|---|
| Dutch Co-operative Head and Neck Group | View source |
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| ID | Term |
|---|---|
| D010025 | Osteoradionecrosis |
| ID | Term |
|---|---|
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D006931 | Hyperbaric Oxygenation |
| ID | Term |
|---|---|
| D010102 | Oxygen Inhalation Therapy |
| D012138 | Respiratory Therapy |
| D013812 | Therapeutics |
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| 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. | one year after therapy in the arm assigned to. |
| Use of pain medication | type and quantity | 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 | 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) | one year after therapy in the arm assigned to. |
| Cost effectiveness | Questionnaire EQ-5D | one year after therapy in the arm assigned to. |
| Amsterdam |
| Netherlands |
| University Medical Center Groningen | Groningen | Netherlands |
| Leiden University Medical Center | Leiden | 2333ZA | Netherlands |
| Maastricht Universitary Medical Centre | Maastricht | 6229HX | Netherlands |
| Radboud University Nijmegen Medical Centre | Nijmegen | 6525GA | Netherlands |
| Erasmus University Medical Center | Rotterdam | 3015CE | Netherlands |
| University Medical Center Utrecht | Utrecht | 3584CX | Netherlands |