In-Bedroom Renewed Air as Anti-inflammatory Adjuvant Therapy in Cancer Survivors
Trial Parameters
Brief Summary
The BREATHS trial aims to investigate whether overnight in-bedroom air filtration reduces inflammation and cardiac biomarkers in adult survivors of cancer who are at high risk for cardiovascular complications. The study consists of individualized experiments (N-of-1 trials) conducted in the home settings of adults residing in densely populated urban areas with the most severe air quality levels in Valencia, Spain, where fine particulate matter (PM2.5) and nitrogen dioxide levels exceed the limits set by the World Health Organization (WHO) and EU Directive. Participants will be exposed to 3 treatment sets (blinded phase), each consisting of a 14-day period of filtered air using a portable air filtration unit ("true-HyperHepa) and a 14-day period of unfiltered air (using the same portable unit with "sham filters"). The intervention will be administered nightly for a minimum of 7 consecutive hours and will last between 4 and 12 weeks for each participant, contingent upon the demonstration of clinical benefit, defined by a reduction in the levels of the blood biomarker C-reactive protein. An unblinded phase will be implemented for participants who do not experience a clinically meaningful change in CRP. During this phase, they will undergo a 14-day period without treatment, followed by 14-day period of both nightly and daily filtered air therapy. The primary endpoint of this study is defined as the change in blood concentrations of CRP. The secondary endpoints include the changes in levels of three other noninvasive blood biomarkers associated with inflammation and cardiovascular health, and blood pressure. Both indoor and outdoor fine particulate matter (PM2.5) exposure concentrations will be continuously monitored in the study.
Eligibility Criteria
Inclusion Criteria: * Adult-onset cancer survivors with a diagnosis of breast, colon, colorectum, rectum, prostate, non-small lung, Hodgkin lymphoma, non-Hodgkin lymphoma, chronic lymphoid leukaemia and chronic myeloid leukaemia cancer. * Aged ≥ 18 years at cancer diagnosis -upper age limit to study entry = 75 years. * People of both genders, all racial and ethnic backgrounds. * Non-smokers (i.e., not smoking during previous 12 months). * A history of local, regional or distant recurrence, primary second cancers or multiple primary tumours will be not reasons to exclude. * No previous evidence for metastatic disease. * Evidence of complete remission defined as a decrease in or disappearance of signs and symptoms of cancer after treatment. * Having completed definitive treatment (surgery, neoadjuvant/adjuvant cytotoxic chemotherapy, radiotherapy, immunotherapy) at least 12 months. * Continuous, maintenance therapy is considered if initiated ≥3 months prior to study treatment and prescri