PenVe trial
Research type
Research Study
Full title
A feasibility study of a prospective randomised controlled trial comparing the use of open label pentoxifylline and tocopherol versus current standard of care for the prevention of fibrosis related outcomes in irradiated head and neck oncology patients. PenVe
IRAS ID
223295
Contact name
Vinod Patel
Contact email
Sponsor organisation
Guy's and St Thomas' Foundation NHS Trust
Eudract number
2018-001153-27
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Research Summary:
This study is a phase II randomised control trial in the Head and Neck Cancer service at Guy’s and St Thomas' NHS foundation trust (GSTFT). The trial has an open label, parallel two arm, prospective design, and is funded by the NIHR Central Commissioning Facility (CCF).
The trial will enrol head and neck cancer patients undergoing radiotherapy treatment at GSTFT and aims to show whether fibrosis (caused by the passing of radiation through the jaw bones) can be avoided, delayed or slowed down via the use of two investigational medicines taken simultaneously (pentoxifylline, vitamin E). Fibrosis is microscopic scarring and hardening of the jaw muscles, leading to stiffness and difficulty swallowing.
Over time fibrosis can lead to osteo-radio-necrosis (commonly shortened to ORN). As radiation is passed through the jaw bones the bone can become necrotic or ‘dead,’ causing pain and infection. There remains no guaranteed treatment to reverse or cure this and the limited treatment methods proposed have shown varying degrees of success. As the fibrosis continues to become more advanced the ability to reverse this becomes increasing difficult to near impossible.
In this research we will randomise participants requiring head and neck radiotherapy as part of their standard treatment for cancer, to one of two groups. Both groups will continue to receive best standard of care in current practice, but group b will additionally receive the Pentoxifylline 400mg BD & Tocopherol 1000IU OD after their radiotherapy. Group B will also receive additional follow up calls. All participants will be in the trial for 6 months and have 4study visits.
Summary of results:
Head and neck radiation therapy is known to cause potential long term side effects such as osteoradionecrosis (exposed jaw bone), trismus (jaw stiffness) and dysphagia (difficult swallowing). The current trial aimed to investigate whether 2 medicines (pentoxifylline & vitamin E) if taken together soon after radiotherapy would reduce the onset or severity of these side effects and their impact on participant's quality of life.
A trial to investigate this would require hundreds of patients and it is not known whether patients would agree to take part, stay in the study, take the medicines and the extent of side effects they would experience taking the medicines at this stage. Therefore, the trial's main focus was to address and answer these questions first via a smaller group of patients. We would also collect the clinical information but with a small group of patients it was known that this would not answer the clinical question. This would be addressed in later second larger trial based upon identifying and solving problems found in a smaller version. This is often referred to as a feasibility study which is what this trial was.
The feasibility study found 102 patients who were eligible and 83 were invited to participate with 54 agreeing. In total,
22 took part or completed the trial. Numerous reasons for withdrawal were identified. Most commonly participants were no longer eligible to take part after completing their cancer care (11 participants) or COVID led to trial interruption leading to trial ineligibility. Most patients preferred the medicines in tablet format. No patients clinically had ORN at 6 months. Statistical analysis was not possible for the results on swallowing, quality of life and trismus.
The data achieved from this feasibility has been valuable and will allow a more accurate design of a larger trial.REC name
London - Harrow Research Ethics Committee
REC reference
18/LO/1910
Date of REC Opinion
22 Feb 2019
REC opinion
Further Information Favourable Opinion