Table 2 Exclusion criteria for the SAVER trial
Exclusion criteria | |
1. Synchronous or metachronous OSCC (i.e. at time of screening or within 6 months) | |
2. Active malignancy outside head and neck region (with exception of non-melanoma skin cancer) | |
3. Currently positive for COVID-19 (patients who have recovered from COVID-19 are NOT excluded) | |
4. OSCC susceptible conditions e.g. Fanconi anaemia, Blooms syndrome, ataxia-telangectasia and Li-Fraumeni syndrome | |
5. Clinical and/or histopathological diagnosis of oral submucous fibrosis | |
6. Immunosuppression. However, low dose i.e. < 10mg/day prednisolone, or equivalent steroid, (as per BNF conversion table), are not considered an exclusion. | |
7. Chronic previous or current use of sodium valproate | |
8. Diagnosed epilepsy that has chronic previous or current use of any antiepileptic therapy | |
9. Obesity (body mass index ≥ 30) | |
10. Known relative or absolute contraindications to Sodium Valproate (as listed in British National Formulary), and specifically: | |
a. Acute porphyria | |
b. Known or suspected mitochondrial disorders | |
c. Personal or family history of severe hepatic dysfunction, current hepatic dysfunction (as evidenced by LFTs outwith reference range and prolonged prothrombin time) | |
d. Past history or current pancreatitis | |
e. Women with child-bearing potential. A woman is considered of childbearing potential (WOCBP), i.e. fertile, following menarche and until becoming post-menopausal unless permanently sterile. Permanent sterilisation methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy. | |
f. Potential drug interactions (particularly antipsychotic and anticonvulsant medications, MAO inhibitors, antidepressants, benzodiazepines), specifically patients taking phenobarbital, primodone, carbopenem antibiotics (imipenem, panipenem, meropenem), cimetidine, erythromycin, lamotrigine, olanzapine, pivmecillinam, sodium oxybate, zidovudine, carbamazepine, phenytoin, rifampicin, high dose salicylates including aspirin > 75 mg daily (patients taking low dose aspirin 75 mg daily are eligible). | |
g. Patients with suicidal ideation and behaviour should be excluded from the trial. Patients should also be monitored for signs of suicidal ideation and behaviours and appropriate treatment should be considered. | |
h. Patients with known or suspected mitochondrial disease, systemic lupus erythematosus or hyperammonaemia |