Osteoradionecrosis, trismus and dysphagia MedDRA version: 20.1 Level: PT Classification code 10067352 Term: Osteoradionecrosis System Organ Class: 10022117 - Injury, poisoning and procedural complications MedDRA version: 21.1 Level: PT Classification code 10044684 Term: Trismus System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders MedDRA version: 20.0 Level: PT Classification code 10013950 Term: Dysphagia System Organ Class: 10017947 - Gastrointestinal disorders
Conditions
Interventions
Product Name: Pentoxifylline 200mg/5ml solution
Pharmaceutical Form: Oral suspension
INN or Proposed INN: PENTOXIFYLLINE
CAS Number: 6493-05-6
Other descriptive name: 3,7-dimethyl-1-(5-oxohexyl)purine
Sponsors
Guy's and St Thomas' NHS Foundation Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Patients (=18yrs) presenting with a primary head and neck (H&N) tumour requiring radiotherapy treatment and placing them in the highest risk group for developing osteoradionecrosis, trismus and dysphagia. These include: o Oropharynx (Tonsil, Base of Tongue) o Nasopharynx o Oral cavity o Maxillary sinus o Salivary glands o Unknown primary of the neck o Hypopharynx •Oncology treatment aiming for the intent to cure •Patients able to consent and willing to participate Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 68 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 68
Exclusion criteria
Exclusion criteria: • Previous history of H&N cancer • Patients treated with any drug implicated to cause medication related osteonecrosis of the jaw (MRONJ). These include bisphosphonates, denosumab, radium 223, tyrosine kinase inhibitors and bevacizumab • Any patient with significant medical history where taking part in this study may potentially compromises their health. • Women who are pregnant or breast feeding or of child bearing age not on adequate contraception • Patients lacking capacity to consent. • Oncology treatment for palliative care • Patients deemed to have a high risk of recurrent tumour • • Patients with cerebral haemorrhage, extensive retinal haemorrhage, acute myocardial infarction, severe cardiac arrhythmias and /or impaired renal function, impaired liver function which in the expert opinion of the principal investigator present a risk to the patient • Known drug allergy or sensitivity to pentoxifylline (or methyl xanthines) and alpha-tocopheryl or any constituents of the medication (e.g. methyl and propyl hydroxybenzoates or a rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency) • Patients taking theophylline or oestrogens • Patients with metastatic disease • Patients participating in other drug (CTIMP) trials
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the feasibility of a randomised controlled trial of pentoxifylline in combination with vitamin E (PVe) for the prevention of radiation induced fibrosis outcomes in head and neck radiotherapy patients compared to best standard of care. •To assess patient’s preference for pentoxifylline and vitamin E formulation, in a tablet vs liquid format (Intervention group only) •To assess patient’s subsequent side effects related to the pentoxifylline and vitamin E (Intervention group only) • To assess the recruitment into the trial • To assess retention of the participants in the trial • To assess the participation in the trial follow up visits and phone calls • To assess patient adherence to pentoxifylline and Vitamin E (Intervention group only) • To assess the acceptability to participants of the outcome measurement tools ;Secondary Objective: •To assess the presence of osteoradionecrosis compared to the non-intervention arm •To assess an improved mouth opening compared to the non-intervention arm •To assess an improved swallowing capacity compared to the non-intervention arm •To assess an improved quality of life compared to the non-intervention arm ;Timepoint(s) of evaluation of this end point: All endpoints will be obtained by measurements taken during the study visits and through patient contact. ;Primary end point(s): To assess the feasibility of a randomised controlled trial of pentoxifylline in combination with vitamin E (PVe) for the prevention of radiation induced fibrosis outcomes in head and neck radiotherapy patients compared to best standard of care, through: Assessing patients preference for pentoxifylline and vitamin E formulation, in a liquid vs tablet format - The time point that the participant agrees to swap from liquid to tablet formulation of pentoxifylline and vitamin E. - Patients self reported preference for tablet or liquid Assessing patients subsequent side effects related to the pentoxifylline and vitamin E - The | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To assess the presence of osteroradionecrosis - Proportion of patients with osteoradionecrosis at month 6 post randomisation To assess the improvement in mouth opening - Difference in mouth opening measurements from baseline to month 6 post randomisation To assess improvement in swallowing capacity - Difference in swallowing scores from baseline to month 6 post randomisation To assess improvement in quality of life - Difference in quality of life scores from baseline to month 6 post randomisation;Timepoint(s) of evaluation of this end point: Baseline, month 3 (post randomisation) and month 6 (post randomisation). | — |
Countries
United Kingdom
Contacts
Public ContactMr Vinod Patel,
Guy's and St Thomas' NHS Foundation Trust
Outcome results
None listed