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Efficacy of Hyperbaric Oxygen Therapy in the Treatment of Osteoradionecrosis

Primary Purpose

Osteoradionecrosis

Status

Terminated

Phase

Phase 2

Locations

Netherlands

Study Type

Interventional

Intervention

hyperbaric oxygen

About this trial

This is an interventional treatment trial for Osteoradionecrosis focused on measuring osteoradionecrosis, mandible, radiotherapy, hyperbaric oxygen therapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Surgery

Hyperbaric oxygen therapy with surgery

Arm Description

This is the standard arm. Surgery without hyperbaric oxygen treatment

Intervention arm. Hyperbaric oxygen therapy with surgery.

Outcomes

Primary Outcome Measures

absence of exposed bone, fistulae or ulceration.

Secondary Outcome Measures

Pain score

Clinical and radiological assessment of the treatment response

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.

Use of pain medication

Type of surgical intervention (sequestrectomy, marginal mandibula resection, segment resection)

Quality of life

Cost effectiveness

Full Information

NCT ID

NCT00989820

First Posted

October 5, 2009

Last Updated

May 29, 2017

Sponsor

Radboud University Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT00989820

Brief Title

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

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Terminated

Why Stopped

Recruitment problems, patients refused to participate

Study Start Date

October 2009 (Actual)

Primary Completion Date

May 1, 2017 (Actual)

Study Completion Date

May 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Radboud University Medical Center

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoradionecrosis

Keywords

osteoradionecrosis, mandible, radiotherapy, hyperbaric oxygen therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Surgery

Arm Type

No Intervention

Arm Description

This is the standard arm. Surgery without hyperbaric oxygen treatment

Arm Title

Hyperbaric oxygen therapy with surgery

Arm Type

Experimental

Arm Description

Intervention arm. Hyperbaric oxygen therapy with surgery.

Intervention Type

Drug

Intervention Name(s)

hyperbaric oxygen

Other Intervention Name(s)

Linde Gas Therapeutics Benelux B.V., RVG 30355, ATC code V03AN012

Intervention Description

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

Primary Outcome Measure Information:

Title

absence of exposed bone, fistulae or ulceration.

Time Frame

12 months after finishing therapy in the arm assigned to

Secondary Outcome Measure Information:

Title

Pain score

Time Frame

one year after primairy therapy assigned to.

Title

Clinical and radiological assessment of the treatment response

Time Frame