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Clinical Trials/ISRCTN14224600
ISRCTN14224600
Completed
未知

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

The Newcastle Upon Tyne Hospitals NHS Foundation Trust0 sites380 target enrollmentMarch 28, 2017
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Overview

Phase
未知
Intervention
Not specified
Conditions
Not specified
Sponsor
The Newcastle Upon Tyne Hospitals NHS Foundation Trust
Enrollment
380
Status
Completed
Last Updated
2 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

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

Registry
who.int
Start Date
March 28, 2017
End Date
December 31, 2019
Last Updated
2 years ago
Study Type
Interventional
Sex
All

Investigators

Eligibility 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

  • •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

Outcomes

Primary Outcomes

Not specified

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