Feasibility study of Treatment of Oral Mucositis from Radiotherapy
Research type
Research Study
Full title
A feasibility study of Treatment of Oral Mucositis due to Radiotherapy In Cancer of the head and neck (TOMRIC)
IRAS ID
361112
Contact name
Saul Berkovitz
Contact email
Sponsor organisation
University of West London
ISRCTN Number
ISRCTN14452933
Duration of Study in the UK
0 years, 11 months, 31 days
Research summary
This feasibility trial will evaluate all aspects of the research process and inform the design of a fully-powered, pragmatic randomised controlled multi-centre clinical trial investigating the effect of turmeric on oral mucositis in head and neck cancer participants undergoing radiotherapy.
The study will employ a pragmatic mixed methods randomised parallel-group exploratory design to determine the feasibility of giving turmeric within an NHS cancer care setting. The study will compare turmeric plus standard care versus standard care alone. Participants will be allocated to treatment arms by computer generated randomisation. Participants will complete baseline outcome measures and be asked to complete follow-up outcome measures weekly during radiotherapy, and one month post-radiotherapy treatment. At two months post-radiotherapy treatment, all participants will be invited to participate in a qualitative interview to explore their views on the design of the trial, and for those allocated to the turmeric arm, their views on the intervention. Participants will be randomised using a ratio of 1:2 standard care to turmeric. Participants in the standard care arm will be offered the turmeric intervention at the end of the trial to deal with any ongoing oral mucositis.
The aims of the feasibility trial include determining the acceptability of the selected questionnaires and participant’s willingness to complete them, as well as determining the usefulness of the study outcome measures. Participants will self-complete the study outcome measures except for the clinician-determined assessment of oral mucositis severity. Assessment of OM severity will be conducted by clinical staff (clinical nurse specialists and radiotherapists , “blinded”, i.e. unaware of allocation to study arms) before each treatment session.
REC name
Wales REC 5
REC reference
25/WA/0370
Date of REC Opinion
13 Jan 2026
REC opinion
Further Information Favourable Opinion