LiTEFORM light therapy effectiveness for oral mucositis

Clinical effectiveness and cost effectiveness of LLLT plus standard care vs standard care alone is measured by comparing the OMWQ-HN score at 6 weeks following the start of radiotherapy (+/- 2 weeks) in the two randomised arms.

1. Effectiveness of LLLT in preventing severe oral mucositis during radiotherapy for head and neck cancer is measured using OMWQ-HN and WHO mucositis at baseline and weekly during 1 to 6 of LLLT
2. Long term reported health related quality of life as measured by EORTC QLQ C30 (version 3.0), EORTC QLQ C30/H&N 35 (EORTC QOL Module for Head and Neck Cancer) and the EQ-5D-5L at baseline, week 6, month 4 and month 14, and MDADI at baseline, week 6, month 4 and month 14
3. Nutritional Parameters as measured by Performance Status Scale’s (PSS-HN) collected weekly at baseline, weeks 1-6, month 4 and month 14. Recording of weekly weight changes from baseline during treatment, the quantity of enteral nutrition consumed, number of days of feeding tube in situ
4. Changes in swallowing function measured by the timed water swallow test collected at baseline, week 6 of LLLT month 4 and month 14
5. Pain outcomes as measured by use of analgesics/ topical treatment and pain domain of EQ-5D-5L and OMWQ-HN at randomisation and weekly to week 6 during treatment
6. Safety, specifically adverse events attributed to LLLT and clinical complications notably number of days as inpatient hospital admissions and interruptions in CRT treatment (recorded weekly 1-6 during treatment)
7. Clinical outcomes specifically patient survival, quality-adjusted survival recurrence and persistence of disease at 14 months

Economic outcomes:
1. Incremental cost per change in OMWQ-HN score recorded between baseline and at week 6 of therapy and incremental cost per QALY over 14 months
2. Quality-adjusted life years based upon EQ-5D-5L and EORTC-8D utility scores measured at baseline, week 6 and 4 and 14 months
3. Costs associated with treatment (weeks 0-6) will be collected weekly via the eCRFs (e.g. adverse events and use of analgesics)
4. Health care utilisation based on responses to Health Utilisation Questionnaire administered at 4 and 14 months (assessing: visits to the GP/walk-in clinic/A&E etc.)
5. Participant and family costs collected via the Time and Travel Questionnaire administered at 14 months
6. Total costs of LLLT and sham LLLT measured at 4 and 14 months, from the perspective of the NHS and personal and social services to participants and families

Qualitative outcomes as identified through measurement of:
1. Observations of site initiation visits and device training conducted prior to the opening of each site
2. Interviews with health professionals delivering LLLT conducted and other relevant members of head and neck cancer team throughout the trial using purposeful sampling, with no more than 2 interviews per staff member
3. Interviews with patients, at 1-2 weeks after the recruitment discussion, and at approximately month 4 or month 14. There will be no more than 2 interviews per patient