Table 1

Data collection schedule

Registration*Allocation*After allocationEndCancel
RT start
±7 days
Onset of grade 1 mucositis and no onset of candidiasisAt least once a weekOnset of grade 3 mucositis or RT end
Assessment of eligibility criteria
Obtain consent
Patient Characteristics†
Oral examinations‡
Start of RinderonV administration§
Adverse events
Treatment-related factors¶
  • *The registration date and allocation date may be the same day.

  • †Age, sex, smoking habit, drinking habit, use of denture, primary tumour site, surgery before RT, scheduled RT dose, haemoglobin, albumin and creatinine before RT.

  • ‡Oral mucositis (CTCAE V.3.0 and V.5.0), oral candidiasis.

  • §These would be evaluated only in the betamethasone group.

  • ¶Total RT dose, RT method, irradiation area, concurrent therapy, number of teeth, spacer, mouth wash containing local anaesthetics, opioids, pilocarpine hydrochloride, minimum value of white cell count and lymphocyte count during RT.

  • RT, radiation therapy.