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

Phase 1

• Conditions: Osteoradionecrosis, trismus and dysphagia; MedDRA version: 20.1Level: PTClassification code 10067352Term: OsteoradionecrosisSystem Organ Class: 10022117 - Injury, poisoning and procedural complications; MedDRA version: 21.1Level: PTClassification code 10044684Term: TrismusSystem Organ Class: 10028395 - Musculoskeletal and connective tissue disorders; MedDRA version: 20.0Level: PTClassification code 10013950Term: DysphagiaSystem Organ Class: 10017947 - Gastrointestinal disorders; Therapeutic area: Diseases [C] - Mouth and tooth diseases [C07]

• Registration Number: EUCTR2018-001153-27-GB
• Lead Sponsor: Guy's and St Thomas' NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-10-11
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 68

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:
oOropharynx (Tonsil, Base of Tongue)
oNasopharynx
oOral cavity
oMaxillary sinus
oSalivary glands
oUnknown primary of the neck
oHypopharynx

•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

• 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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified