Skip to main content

Table 2 Summary of events

From: Cancer Precision-Prevention trial of Metformin in adults with Li Fraumeni syndrome (MILI) undergoing yearly MRI surveillance: a randomised controlled trial protocol

  1. aPregnancy test (urine) for participants of child-bearing potential and who are sexually active
  2. bPharmacodynamic sample PD1
  3. cPharmacodynamic sample PD2
  4. dFasting biochemistry and haematology blood: FBC (Hb, WBC, platelets), biochem (sodium, potassium, urea, creatinine, eGFR, liver function tests, vitamin B12 (baseline and year 5 only)) and for the translational research endpoints: insulin, glucose and IGF1 (baseline and M12)
  5. eWhole body and brain MRI (WB-MRI) to be performed at the investigator (recruiting) sites. If a whole body and brain MRI scan has been completed in the 3 months prior to randomisation, this will be accepted as the baseline and screening scan.
  6. fQuality of Life questionnaires: 12-item short form survey (SF12V2), Cancer Worry Scale & Treatment Burden Questionnaire (TBQ)
  7. gTelemed call metformin arm*: Initial screening—explain randomisation outcome and call structure. Management of dose-titration phase, determine adverse events, changes to concomitant meds and review of adherence (MARS-5 Medication Adherence Questionnaire from month 6 onwards).
  8. hTelemed call control arm*: Screening—explain randomisation outcome and call structure. From month 6 to determine adverse events, changes to concomitant meds.
  9. iTumour tissue: Paraffin-embedded diagnostic tumour tissue or pre-cancerous tissue block
  10. jMetformin administration: metformin will be sent by post from the recruiting hospital pharmacy
  11. *For both arms, additional telemed calls may be made by the telemed team
Back to article page

Trials

ISSN: 1745-6215