Circadian and gut-brain axis modulation is associated with neuroimmune and symptom recovery after rectal cancer surgery: An exploratory randomized controlled trial
Abstract
BACKGROUND
Disruption of circadian and neuroimmune regulation after rectal cancer surgery contributes to psychological distress, inflammation, and impaired recovery. This exploratory randomized controlled trial evaluated whether a perioperative multicomponent behavioral program targeting circadian and gut-brain processes was associated with improvements in neuroimmune profiles and symptom outcomes.
METHODS
A total of 184 patients with stage I-III low rectal cancer undergoing ultra-low anterior resection were randomized to receive either standard ERAS care or an integrative perioperative intervention that combined emotion-regulation strategies (mindfulness-based stress reduction, heart-rate-variability biofeedback, neurofeedback) with structured sleep and circadian therapy (cognitive behavioral therapy for insomnia, controlled-release melatonin, circadian scheduling). Co-primary outcomes were depressive symptoms (Beck Depression Inventory-II) and sleep quality (Pittsburgh Sleep Quality Index) at 6 months. Secondary outcomes included inflammatory markers (C-reactive protein, interleukin-6, tumor necrosis factor-α), gastrointestinal recovery indices, and skeletal muscle index (SMI). Disease-free and overall survival were examined as pre-specified exploratory endpoints.
RESULTS
Compared with standard care, the integrative intervention was associated with greater 6-month improvements in depressive symptoms and sleep quality (both p < 0.01), lower postoperative inflammation (e.g.,…
How strong is the evidence?
Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 184 participants or records.
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