iTEFORM light therapy effectiveness for oral mucositis

Not Applicable

Completed

• Conditions: Head and neck cancer; Cancer; Head, face and neck

• Registration Number: ISRCTN14224600
• Lead Sponsor: The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Brief Summary

2022 Results article in https://pubmed.ncbi.nlm.nih.gov/36484364/ (added 12/12/2022)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-28
• Study Completion: 2019-12-31
• Last Update Posted: 1 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 380

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified