Protocol for the TMaC Study: A Patient-Blinded, Randomised, Sham-Controlled, Parallel-Group Study Evaluating Effects...

Chemotherapy-induced peripheral neuropathy (CIPN) is a common and debilitating consequence for people undergoing treatment for cancer, especially bowel cancer. Painful CIPN contributes to psychological distress, functional decline and reduced quality of life. Additionally, it is a dose-limiting factor for anticancer agents, compromising chemotherapy effectiveness and patient survival. To date, no effective long-term management options exist for painful CIPN. Whilst evidence suggests analgesic effects of repetitive transcranial magnetic stimulation (rTMS), little is known regarding its effectiveness specifically for CIPN-associated pain. The proposed study aims to evaluate the analgesic potential of rTMS in bowel cancer survivors, quantify the duration of symptom alleviation, and explore patient perspectives on using rTMS for CIPN management.

Participants will be randomised into two parallel groups (allocation ratio 1:1) to receive rTMS or sham stimulation over four sessions, with each session separated by a minimum of 7 days. Pain scores will be obtained immediately before and after each treatment session, as well as at 8-week and 6-month follow-up sessions using the Visual Analogue Scale for Pain (P-VAS) as the primary outcome. P-VAS scores, along with secondary outcome measures of pain and dysaesthesia, will be compared within and between groups across time to assess short-term and long-term effectiveness of rTMS. An interview will be conducted upon completion of all treatment sessions at the 8-week follow-up for qualitative analysis of patients' acceptance of routine rTMS for pain management.

Findings may provide a promising long-term solution to alleviate symptoms of CIPN and enhance quality of life in bowel cancer survivors.