Clinical trials are needed to advance interventions such as chemoprevention that have potential to reduce the risk of malignant transformation in individuals with oral potentially malignant disorders. We explored the perspectives of those screened or invited to join an early phase clinical trial (the SAVER trial: Sodium valproate for the epigenetic reprogramming of high-risk oral epithelial dysplasia). Our objectives were to inform the SAVER trial while it was ongoing and to provide insights for future trials and chemoprevention therapy development more broadly.

Qualitative study involving audio-recorded, semistructured interviews. Analysis of transcribed interviews drew on thematic approaches.

Five UK-based sites involved in SAVER.

Purposive sample of individuals (n=20) with suspected or diagnosed oral epithelial dysplasia (OED) who were approached about SAVER.

Most interviewees readily accepted that OED warranted preventive treatment and were positive about the potential of chemoprevention. However, they were often concerned about the side effects of the trial medication, and together with a dislike of biopsies and a perception that the trial might disadvantage treatment, these concerns made some hesitant to participate in SAVER. Interviewees indicated that the communication of staff influenced their understanding and experience of the trial and identified several opportunities for enhancing these aspects.

In indicating that individuals at risk of malignant transformation are accepting of chemoprevention in principle, our findings are supportive of future research on chemoprevention for this group. The findings also draw attention to the crucial role of communication in recruitment to chemoprevention trials. We provide recommendations to support staff during recruitment and enhance individuals’ experience of the trial.

ISRCTN12448611; Pre-results.