1. 1 Randomised Pilot Study of Therabite® versus Wooden spatula in the Amelioration of Trismus in Patients with Head and Neck Cancer. (Trismus Trial) Rana Lee NIHR RfPB grant funded Chief Investigator: Prof Nick Slevin

2. 2 Background Trismus is: Under recognised Under reported RT will exacerbated trismus (Scherpenhuizen et al., 2015) Consequences: Reduced Function Increased risk of depression/suicide More NHS resources

3. 3 Trial Design Surgery Wooden Spatula Therabite 3 month Follow Up Mouth opening QoL + CSRI AEs Patient compliance 6 month Follow Up Mouth opening QoL + CSRI AEs Patient compliance Post operative radiotherapy +/- chemotherapy 3/4 weeks post surgery and 2/3 weeks pre radiotherapy R A N D O MI S A T IO N +/- induction chemotherapy Wooden Spatula Therabite 3 month Follow Up Mouth opening QoL + CSRI AEs Patient compliance Primary chemo- radiotherapy 2/3 weeks pre chemo- radiotherapy R A N D O MI S A T IO N 6 month Follow Up Mouth opening QoL + CSRI AEs Patient compliance Patients with subjective jaw tightening that had or

4. 4 Objectives The Primary Outcome Measure is Change in Mouth Opening Secondary outcome measures are: –Adherence to intervention –Health-related quality of life –Health Economic analysis

5. 5 Statistical Design The null hypothesis will be that there is no difference in the amount of mouth opening at six months between the two arms of the trial The alternative will be 2 sided: it is unspecified which arm will result in more or less mouth opening A total of 112 patients will be recruited

6. 6 Schedule of assessments

7. 7 Results 37 patients were randomised Therabite (T) 34 the wooden spatulas(WS). Mean post intervention mouth opening increased in both groups. After adjustment for baseline MO, centre, surgery and chemoradiation, there was no difference (T – WS) in average mouth opening at the ‘6 month’ assessment. (p=0.39). Acceptability of exercises’ in both groups were comparable.

8. 8 Nested qualitative study Semi-structured interviews with 15 patients Patients’ experiences of acceptability of exercises and compliance with exercises Participants had completed at study at time of the interview Framework analysis (Ritchie & Spencer, 1994)

9. Results: semi –structured telephone interviews Allow patients to have more of a say in the exercise regimen to aid compliance. Exercises 3 times a day. Take a variable break of up to 6 weeks when side effects from RT are at their worst. Prolong study/exercises to 9 months post intervention. 9

10. Results Client Service Receipt Inventory (CSRI) At 6 months, CSRI showed no significant difference (p>0.05) in the frequency of both primary and secondary care contacts between the 2 groups. T costs were £385 per patient higher than WS and had a QALY loss of 0.0137 (equating to a difference of 5 quality-adjusted days over a year in favour of WS. 10

11. 11 Conclusions Prophylactic exercises during radiotherapy treatment can ameliorate trismus but recruitment was low. Both T and WS were acceptable to patients but compliance was a problem. Exercise regime needs to be more flexible CSRI comparable WS cheaper What next: Large multicentre RCT?

12. 12 Acknowledgements MDT Teams at Christie, Aintree and Birmingham Trismus study TMG Members: S.N. Rogers, A.L. Caress, A. Molassiotis, R. Edwards, D. Ryder, P. Sanghera, C. Lunt, T. Yeo, P.Keeley, B. Scott, N. Slevin. NIHR RfPB Award Ref. No. PB-PG-0610-22317 for funding. Patient representative (Alfred Owen).