Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis
This study is currently recruiting participants.
Verified July 2011 by Radboud University
Sponsor:
Radboud University
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00989820
First received: October 5, 2009
Last updated: August 10, 2011
Last verified: July 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Osteoradionecrosis |
Drug: medical oxygen |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis). |
Resource links provided by NLM:
Further study details as provided by Radboud University:
Primary Outcome Measures:
- absence of exposed bone, fistulae or ulceration. [ Time Frame: 12 months after finishing therapy in the arm assigned to ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Pain score [ Time Frame: one year after primairy therapy assigned to. ] [ Designated as safety issue: No ]
- Clinical and radiological assessment of the treatment response [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
- 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. [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
- Use of pain medication [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
- Type of surgical intervention (sequestrectomy, marginal mandibula resection, segment resection) [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
- Quality of life [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
- Cost effectiveness [ Time Frame: one year after initial therapy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 132 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2013 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
No Intervention: Surgery
This is the standard arm. Surgery without hyperbaric oxygen treatment
|
Drug: medical 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
Other Names:
|
|
Experimental: Hyperbaric oxygen therapy with surgery
Intervention arm. Hyperbaric oxygen therapy with surgery.
|
Drug: medical 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
Other Names:
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00989820
Contacts
| Contact: Francois Dieleman, MD DMD | +31 24 361 45 61 | hbot2009@gmail.com |
Locations
| Netherlands | |
| NKI/AvL | Recruiting |
| Amsterdam, Netherlands, 1066CX | |
| Contact: Ludi Smeele, MD DMD PhD | |
| Principal Investigator: Ludi Smeele, MD DMD PhD | |
| VU University Medical centre | Recruiting |
| Amsterdam, Netherlands | |
| Contact: Remco De Bree, MD PhD | |
| Principal Investigator: Remco De Bree, MD PhD | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands | |
| Contact: Max Witjes, MD DMD PhD | |
| Principal Investigator: Max Witjes, MD DMD PhD | |
| Leiden University Medical Center | Not yet recruiting |
| Leiden, Netherlands, 2333ZA | |
| Contact: Richard Van Merkesteijn, MD DDS PhD | |
| Principal Investigator: Richard Van Merkesteijn, MD DDS PhD | |
| Maastricht Universitary Medical Centre | Not yet recruiting |
| Maastricht, Netherlands, 6229HX | |
| Contact: Martin Lacko, MD | |
| Principal Investigator: Martin Lacko, MD | |
| Radboud University Nijmegen Medical Centre | Recruiting |
| Nijmegen, Netherlands, 6525GA | |
| Contact: Francois Dieleman, MD DMD +31 24 361 4561 hbot2009@gmail.com | |
| Principal Investigator: Francois Dieleman, MD DMD | |
| Erasmus University Medical Center | Active, not recruiting |
| Rotterdam, Netherlands, 3015CE | |
| University Medical Center Utrecht | Recruiting |
| Utrecht, Netherlands, 3584CX | |
| Contact: Toine Rosenberg, MD DMD PhD | |
| Principal Investigator: Toine Rosenberg, MD DMD PhD | |
Sponsors and Collaborators
Radboud University
Investigators
| Principal Investigator: | Francois Dieleman, MD DMD | Radboud University Medical Centre |
| Study Director: | Thijs Merkx, MD DMD PhD | Radboud University Medical Centre |
| Study Director: | Hans Kaanders, MD PhD | Raboud University Medical Centre |
More Information
Additional Information:
No publications provided
| Responsible Party: | Francois J. Dieleman MD DMD, Radboud University Medical Centre |
| ClinicalTrials.gov Identifier: | NCT00989820 History of Changes |
| Other Study ID Numbers: | NL20963.091.08 |
| Study First Received: | October 5, 2009 |
| Last Updated: | August 10, 2011 |
| Health Authority: | Netherlands: Medical Ethics Review Committee (METC) Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
Keywords provided by Radboud University:
|
osteoradionecrosis mandible radiotherapy hyperbaric oxygen therapy |
Additional relevant MeSH terms:
|
Osteoradionecrosis Radiation Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 22, 2013