RAPTOR
Research type
Research Study
Full title
Randomised Controlled Trial of PENTOCLO* in Mandibular Osteoradionecrosis *(Pentoxifylline, Tocopherol & Clodronate)
IRAS ID
1005271
Contact name
Richard Shaw
Contact email
Sponsor organisation
University of Liverpool
Eudract number
2022-000728-39
ISRCTN Number
ISRCTN34217298
Research summary
Most treatments for head and neck cancer include radiotherapy, and despite advances in planning and doses, this leaves survivors at risk of significant late effects. One of the most severe complications is osteo-radio-necrosis 'bone death caused by irradiation'. This can affect any bone or cartilage in the head and neck but is commonest in the lower jaw. ORN is characterized by exposure and crumbling of the jaw, severe pain, repeated infections, weight loss, restricted mouth opening, difficulty in chewing and disfigurement. Existing treatments include: i. supportive & conservative methods: long-term antibiotics, antiseptic mouthwash and painkillers ii. surgery which may be curative but is risky, complex and has unpredictable outcomes. Some studies of osteoradionecrosis suggest that a combination of three medications (pentoxyphylline, tocopherol, clodronate: PENTOCLO) may be capable of complete resolution without surgery. Healing in this way is through lifting off of the dead bone fragments leaving intact skin underneath. Some research suggests that just over half of patients get benefit, but this has yet to been proved, particularly in comparison with other treatments This trial proposes to compare PENTOCLO medications against standard supportive medications such as antibiotics, mouthwash and painkillers. Patients will be selected at random for either of the two treatments for at least a year. The trial will also measure pain, side-effects, the need for antibiotics and the instances where deterioration forces the need to resort to surgery instead. Discussion with patients during trial design has resulted in an increased emphasis within the protocol for collection of information on patients' pain and other symptoms, and particularly in providing a 'safety-net' for those patients who are deteriorating. As a result, at 4-monthly clinic visits, patients will report their symptoms (pain, eating, mouth-opening, swelling) every 15 days via their smart device using an App.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0195
Date of REC Opinion
1 Nov 2022
REC opinion
Further Information Favourable Opinion