Clinical trial NCT00989820: Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis
Official title: Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis).
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
PHASE3
Conditions: Osteoradionecrosis
Keywords: osteoradionecrosis
mandible
radiotherapy
hyperbaric oxygen therapy
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2009-10-06
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine whether hyperbaric oxygen therapy is effective in the treatment of osteoradionecrosis (late damage after radiotherapy) of the jaw.

Detailed description: Late radiation damage to the lower jaw (osteoradionecrosis (ORN)) is often seen in patients treated with radiotherapy 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

Eligibility criteria: 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

Primary outcomes:
measure: absence of exposed bone, fistulae or ulceration.
timeFrame: 12 months after finishing therapy in the arm assigned to
Secondary outcomes:
measure: Pain score
timeFrame: one year after primairy therapy assigned to.
measure: Clinical and radiological assessment of the treatment response
timeFrame: one year after initial therapy
measure: 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.
timeFrame: one year after initial therapy
measure: Use of pain medication
timeFrame: one year after initial therapy
measure: Type of surgical intervention (sequestrectomy, marginal mandibula resection, segment resection)
timeFrame: one year after initial therapy
measure: Quality of life
timeFrame: one year after initial therapy
measure: Cost effectiveness
timeFrame: one year after initial therapy
Other outcomes:
Locations:
city: Amsterdam
country: Netherlands
facility: NKI/AvL
city: Amsterdam
country: Netherlands
facility: VU University Medical centre
city: Groningen
country: Netherlands
facility: University Medical Center Groningen
city: Leiden
country: Netherlands
facility: Leiden University Medical Center
city: Maastricht
country: Netherlands
facility: Maastricht Universitary Medical Centre
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre
city: Rotterdam
country: Netherlands
facility: Erasmus University Medical Center
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Radboud University Medical Center
name: Francois Dieleman, MD DMD
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Thijs Merkx, MD DMD PhD
role: STUDY_DIRECTOR
affiliation: Raboud University Medical Centre
name: Hans Kaanders, MD PhD
role: STUDY_DIRECTOR
References: