Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

Osteoradionecrosis Clinical Trial

Official title:

Efficacy of Adding Hyperbaric Oxygen Therapy to the Treatment of Late Radiation Damage of the Lower Jaw (Osteoradionecrosis).

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00989820
• Other study ID #: NL20963.091.08
• Status: Terminated
• Phase: Phase 2/Phase 3
• First received: October 5, 2009
• Last updated: May 29, 2017
• Start date: October 2009
• Est. completion date: May 1, 2018

Study information

• Verified date: April 2016
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 20
• Est. completion date: May 1, 2018
• Est. primary completion date: May 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Osteoradionecrosis

Intervention

Drug:
• hyperbaric 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

Locations

Country	Name	City	State
Netherlands	NKI/AvL	Amsterdam
Netherlands	VU University Medical centre	Amsterdam
Netherlands	University Medical Center Groningen	Groningen
Netherlands	Leiden University Medical Center	Leiden
Netherlands	Maastricht Universitary Medical Centre	Maastricht
Netherlands	Radboud University Nijmegen Medical Centre	Nijmegen
Netherlands	Erasmus University Medical Center	Rotterdam
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	absence of exposed bone, fistulae or ulceration.		12 months after finishing therapy in the arm assigned to
Secondary	Pain score		one year after primairy therapy assigned to.
Secondary	Clinical and radiological assessment of the treatment response		one year after initial therapy
Secondary	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 initial therapy
Secondary	Use of pain medication		one year after initial therapy
Secondary	Type of surgical intervention (sequestrectomy, marginal mandibula resection, segment resection)		one year after initial therapy
Secondary	Quality of life		one year after initial therapy
Secondary	Cost effectiveness		one year after initial therapy

External Links

•   Dutch Co-operative Head and Neck Group