Randomised Controlled Trial of PENTOCLO* in Mandibular Osteoradionecrosis *(Pentoxifylline, Tocopherol & Clodronate)

Trial Summary

Background

Osteoradionecrosis is a complication of radiotherapy following the treatment of head and neck cancer. It is the death of the jawbone caused by irradiation, which leads to infection, pain, and fracture. Patients with osteoradionecrosis can experience difficulties with swallowing, chewing, speech, which can even lead to weight loss and changes in facial appearance. It is estimated that one in fifteen patients treated for head and neck cancer with radiotherapy will develop osteoradionecrosis.

Patient Information Poster

Why are we doing this research

In routine supportive care, osteoradionecrosis is usually treated with painkillers, antibiotics and mouthwashes to control infection, and removal of any sharp or loose bone. In more serious cases, surgery is required to remove all damaged bone and reconstruct the jawbone, which is a very complex major procedure.

PENTOCLO is a combination of Pentoxifylline, Tocopherol, and Clodronate, which are thought to heal the damage caused by radiotherapy. The potential benefits of PENTOCLO are not yet known, which is why we are doing this research. At present we believe at least 12 months of treatment with PENTOCLO is required to see any benefit.

The RAPTOR trial aims to compare standard treatment against standard treatment with the addition of PENTOCLO. The results from this study will be used to help us improve treatments for patients with osteoradionecrosis.

Why me

You have been invited to take part in this study because you have osteoradionecrosis of the lower jaw.

What will happen if I take part

If you agree to take part, you will be asked to sign the consent form at the end of this document. You will be given a copy of the consent form and this information sheet to keep. Once you have signed the consent form, we will check and confirm that this study is suitable for you, and you will be asked to follow the study plan.

When you are entered into the study, you will randomly be allocated to either a standard treatment or standard treatment and PENTOCLO. If you are allocated to PENTOCLO, you will need to take tablets every day for at least one year.

All participants will need to attend hospital visits every three months for at least one year, for a maximum of three years or until the jaw is confirmed to be healing. These visits are considered to be in line with your routine care. At each of these visits, we will repeat the assessments taken at the start of the study.

After one year, you can decide to end the trial or to continue for up to three years, this is at your preference.

At your clinic visits, we ask that you complete a set of questionnaires. These questionnaires will ask about your symptoms and quality of life.

We will also have brief questions about symptoms that can be completed via a smartphone App. We will demonstrate how to use the App and the App will prompt you to report any symptoms you may have every 15 days. This should only take a minute or so. If you don’t use a smartphone we can also collect this data online, or via telephone.

Videos

RAPTOR Launch & Osteoradionecrosis Update Meeting Recording

Collaborators

Study funder

This study has been funded by the National Institute for Health Research's Efficacy and Mechanism Evaluation (EME) Programme (ref: NIHR131050) NIHR Logo

Study Sponsor

University of Liverpool University of Liverpool Logo

Study review and approval

The study has been reviewed by a research ethics committee, who have agreed the study is being conducted in a correct and appropriate manner. The study has also been approved by the Medicines & Healthcare products Regulatory Agency (MHRA).

Participating Sites

RAPTOR is being run in a number of hospitals around the UK, and is being organised by the University of Liverpool. RAPTOR will run at 15 sites across the UK over 2 years. The map below shows the sites that are currently recruiting.

Sites Open to Recruitment

  • Aintree University Hospitals
  • Queen Victoria Hospital, East Grinstead
  • York Hospital
  • Eastman Dental Institute, UCL
  • East Kent Hospitals
  • Leeds Dental Institute
  • Royal Surrey Hospital
  • Broomfield Hospital

Recruitment

Randomised patients

10

Target patients

120

Open sites

8

Target Sites

15

Contact Us

Please feel free to contact the RAPTOR team by any of the means below:

Email: raptor@liverpool.ac.uk

Telephone: 0151 795 1728

Address:
Liverpool Clinical Trials Centre,
University of Liverpool,
Block C,
Waterhouse Building,
1-3 Brownlow Street,
Liverpool
L69 3GL