RCT pilot study of Therabite vs wooden spatula in amelioration of trismus in H&N cancer patients

Abstract

Purpose or Objective: Specific objectives of the study were (i) to assess whether prophylactic exercise intervention prevented the worsening of jaw tightening that would be expected following radiotherapy (ii) to assess whether the Therabite® or wooden spatulas intervention improved patients’ QOL as measured using validated questionnaires; (iii) to assess issues around power for sample size calculations, compliance and practical aspects of running a full RCT in this group of patients and (iv) whether the intervention reduced the level of post-treatment clinicamanagement/health care utilisation required by mouth cancer patients. Material and Methods: All patients had some sense of subjective jaw tightening prior to study entry. Measurements of jaw opening and QOLs were taken pre and post radiotherapy 3 and 6 months. Patients were instructed to follow the 5-5-30 regimen daily, for 6 months. (5stretches, 5times, 30 second hold). Results: 37 patients with stage 3/4 oral/oropharyngeal cancers were randomised to receive the therabite device and 34 the wooden spatulas for jaw exercises. The study has shown that mouth openings had increased on average in both groups following the exercise intervention. There was no statistically significant difference between the two interventions. There were problems with compliance. Lessons learnt from the semi structured telephone interviews, (15 patients) which would aid compliance included: (1) Allow patients to have more of a say in the exercise regimen ie reduce to 3 times a day. (2) Allow patients to take a variable break (up to 6 weeks) from the exercises when side effects of radiotherapy are at their worst. Mucositis, soreness and pain in mouth being reported during last few weeks and 4 weeks post radiotherapy. (3) More regular contact with the patients for encouragement and support. The study was designed to give an indication about the benefits of exercises and to inform feasibility to conduct a larger study. Conclusion: Prophylactic exercises during and after radiotherapy treatment can ameliorate trismus for stage 3 and 4 oral/oropharyngeal cancers. Keyword: Trismus, Radiotherapy This abstract presents independent research funded by the National Institute for Health Research (NIHR) under its Research for Patient Benefit (RfPB) Programme (Grant Ref No: PB-PG-0610-22317). The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health. Sponsor: The Christie NHS Foundation Trust