In-bedroom renewed air as anti-inflammatory adjuvant therapy in cancer survivors: protocol for the randomised, placebo-controlled BREATHS N-of-1 trial series
Abstract
Introduction: Inflammation is causally related to cancer progression and cardiovascular toxicities of anticancer treatments. Fine particulate matter (PM2.5) air filtration lowers interleukin-6 and C reactive protein (CRP) levels in high-risk cardiopulmonary groups, though potential synergistic or confounding effects with routine medications-statins, cyclo-oxygenase-2 inhibitors, beta-blockers-remain poorly understood. Whether overnight in-bedroom PM2.5 air filtration effectively reduces inflammation and prothrombotic biomarkers in survivors of adult-onset cancer at high cardiovascular toxicity risk is unknown.
Methods and analysis: BREATHS is a series of randomised, adaptive, blinded, placebo-controlled N-of-1 trials conducted in densely populated urban areas of Valencia, Spain, during winter when PM2.5 concentrations historically exceed WHO guidelines. Eligible participants are aged ≥18 years with a history of breast, colorectal, prostate, lung or haematological cancer, prior cardiotoxic cancer therapy and CRP ≥3 mg/L. Each participant will undergo up to three cycles, each comprising two 14-day periods of advanced submicron air filtration (clean air delivery rate: 275 m3/hour nightly) or placebo (sham filtration), in random order. Sequence duration ranges from 4 weeks to 12 weeks, depending on whether a clinically meaningful CRP reduction (<2 mg/L or ≥35% relative to placebo) is achieved during active treatment of each cycle. Non-responders will enter an open-label phase…
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.
Read the paper
Related studies
- eggNOG 5.0: a hierarchical, functionally and phylogenetically annotated orthology resource based on 5090 organisms and 2502 viruses
- Online Survival Analysis Software to Assess the Prognostic Value of Biomarkers Using Transcriptomic Data in Non-Small-Cell Lung Cancer
- OptiType: precision HLA typing from next-generation sequencing data
- Nicotinic Cholinergic System and COVID-19: In Silico Identification of an Interaction between SARS-CoV-2 and Nicotinic Receptors with Potential Therapeutic Targeting Implications
- Saccharomyces cerevisiae cells have three Omega class glutathione S-transferases acting as 1-Cys thiol transferases
- Hemolysis at low blood flow rates: in-vitro and in-silico evaluation of a centrifugal blood pump
Go deeper in Evidence Hub
Evidence Hub adds a study data sheet (design, sample size, evidence level, key numbers), an AI summary and a chat grounded in the paper's text.