Can a simple pill combo soften radiation scars? new trial explores.

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Subjects aged ≥18 years at the time of signing the Informed Consent Form * Subjects with diagnosis of radiotherapy-induced fibrosis of the head and neck: trismus and/or dysphagia as defined by the following patient-centred criteria: Trismus: "Does your mouth opening feel restricted" (answer must be yes). Dysphagia: a score of 3 or more on the 10-item Eating Assessment Tool (EAT-10) * Previous History of Head \& Neck Cancer * Previous radiotherapy to the Head \& Neck - minimum 50 Gy completed at least 12 months before screening visit * No history of primary cancer resection and/or reconstructive surgery to anatomical areas involved in swallowing and/or chewing with potential for altered and reconstructed muscular anatomy that may not be amenable to exercise/respond to anti-fibrotic medications (with the exception of diagnostic biopsy/tonsillectomy and neck lymphadenectomy) * Cancer-free for a minimum of 12 months after completion of radiotherapy, (complete clinical/radiological remission; absence of distant metastases) * Able to understand the purpose of the study and willing to sign informed consent. * Able to take study medications orally * Subjects of child bearing potential/potency must adhere to one method of highly effective contraception. * Subject has provided written informed consent * Diagnosis of RIF of the head and neck by patient defined criteria: * Trismus: "Does your mouth opening feel restricted?" Dysphagia: a score of 3 or more on the 10-item Eating Assessment Tool (EAT-10)29 * No history of primary cancer resection and/or reconstructive surgery to anatomical areas involved in swallowing and/or chewing with potential for altered and reconstructed muscular anatomy that may not be amenable to exercise/respond to antifibrotic medications (with the exception of diagnostic biopsy/tonsillectomy and neck dissections) * Able to take study medications orally * Subjects of child-bearing potential/potency must adhere to one method of highly effective contraception Exclusion Criteria: * Concomitant presence of other disorders that may cause trismus or dysphagia (e.g. active temporomandibular joint disorder limiting mouth opening, scleroderma, oral sub mucous fibrosis or other rheumatological or neurological disease) * Subject has recurrent H\&N cancer or second primary H\&N cancer * Subject has a known hypersensitivity to pentoxifylline or other xanthines such as caffeine, theophylline and theobromine or tocopherol (vitamin E). * Subject has a history of acute porphyrias (acute intermittent porphyria, variegate porphyria, hereditary coproporphyria and 5-aminolaevulinic acid dehydratase deficiency porphyria) * Subject has a history of cerebral haemorrhage, extensive retinal haemorrhage or is at risk of increased bleeding including those taking anticoagulants and platelet aggregation inhibitors such as: clopidogrel, eptifibatide, tirofiban, epoprostenol, iloprost, abciximab, anagrelide, NSAIDs other than selective COX-2 inhibitors, acetylsalicylates (ASA/LAS), ticlopidine, dipyridamole * Subject has a history of acute myocardial infarction, coronary artery disease, cardiac arrhythmias * Subject has a active/ongoing hypotension * Subject has a active/ongoing hepatic or renal impairment * Subject has a history of diabetes * Expected non-compliance with treatment interventions or is considered unsuitable for trial participation at the discretion of the treating clinician. * Current pregnancy as confirmed by urine pregnancy test at screening. * Patients with rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency. * Subjects with osteoradionecrosis of the jaw. * Breastfeeding mothers * Subjects with a MIO of \<12mm * Recurrent H\&N cancer or second primary H\&N cancer * History of cerebral haemorrhage, extensive retinal haemorrhage or is at risk of increased bleeding (including those taking anticoagulants and platelet aggregation inhibitors) * History of acute myocardial infarction, severe coronary artery disease, severe cardiac arrhythmias * History of hepatic or renal impairment * Expected non-compliance with treatment interventions or is considered unsuitable for trial participation at the discretion of the treating clinician * Rare hereditary problems of fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase insufficiency