Abstract / Summary
This randomized controlled trial evaluated the effects of anti-inflammatory dietary education on sleep disturbances and inflammatory biomarkers in patients with breast cancer undergoing chemotherapy.
A total of 132 patients with sleep disturbances were randomized to receive either a 12-week anti-inflammatory dietary education program based on the energy-adjusted dietary inflammatory index (E-DII) or usual care. Sleep disturbances were assessed using the Pittsburgh Sleep Quality Index (PSQI) at baseline and at 12 weeks. Additional outcomes included inflammatory biomarkers, E-DII scores, and quality of life (QoL). Treatment effects on continuous outcomes were evaluated using linear mixed-effects models (LMMs) under the intention-to-treat principle. The proportions of participants with sleep disturbance (PSQI ≥ 8) at 12 weeks were compared between groups using a completer analysis.
Of the 132 participants, 116 (87.9%) completed the 12-week assessment. In the completer analysis, the proportion of participants with sleep disturbance at 12 weeks was significantly lower in the intervention group than in the control group (49.2% vs. 78.9%, P < 0.001). The intervention group demonstrated greater reductions in PSQI (β =  - 2.10; 95% CI: - 3.01, - 1.18; P < 0.001) and E-DII scores (β =  - 1.23; 95% CI: - 1.98, - 0.47; P = 0.002) and improved overall QoL (β = 14.07; 95% CI: 8.61, 19.52; P < 0.001). Furthermore, levels of interleukin-1β, interleukin-6, and C-reactive protein were significantly reduced, whereas interleukin-10 increased (all P < 0.05).
Anti-inflammatory dietary education reduced sleep disturbances and improved QoL in patients with breast cancer undergoing chemotherapy and was accompanied by favorable changes in inflammatory biomarkers.
ChiCTR2500097053. Registered on 11 February 2025.