LiTEFORM light therapy effectiveness for oral mucositis

A randomised controlled trial of the clinical and cost effectiveness of low level laser in the management of oral mucositis in head and neck cancer irradiation

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN14224600

Enrollment

380

Registered

2017-03-28

Start date

2017-04-28

Completion date

Unknown

Last updated

2024-04-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and neck cancer Cancer Head, face and neck

Interventions

Patients will be randomised to one of two groups using a method of random permuted blocks of concealed variable block size and stratified by planned treatment (radiotherapy alone or chemo-radiotherapy

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Adults aged =18 years diagnosed with HNC 2. Capacity to provide informed written consent 3. Histological diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, nasopharynx, larynx, hypopharynx or unknown squamous cell primary of head and neck origin histologically confirmed 4. (C)RT patients discussed in a Head and Neck MDT meeting and deemed medically fit for an agreed treatment plan for primary or adjuvant radiotherapy ± concurrent or induction chemotherapy (cisplatin or cetuximab) 5. Patients planned to receive a minimum of 60Gy to a defined clinical target volume in the oral cavity or oropharynx, or neck levels Ia/b as defined by the current RTOG criteria

Exclusion criteria

Exclusion criteria: 1. Known to be pregnant or planning to become pregnant within the trial treatment period 2. Parotid tumours 3. Previous radiotherapy for HNC 4. Current/ongoing OM and trismus limiting laser access for treatment 5. Patients who are experiencing active heavy tumour bleeding from the mouth (haemorrhage) 6. Patients for whom the MDT recommend short course palliative radiotherapy 7. Patients on immune suppressant drugs (except low dose steroids) 8. Participation in other trials assessing different treatments for OM 9. Unable to provide written informed consent

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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. Part	—

Measure

Time frame

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. Part

—

Countries

England, United Kingdom, Wales

Contacts

Public ContactJenn Bingham

jenn.bingham@newcastle.ac.uk+44 191 208 2520

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 10, 2026