In-Bedroom Renewed Air as Anti-inflammatory Adjuvant Therapy in Cancer Survivors

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.

Conditions

• Cancer Survivors
• Cardiotoxicity
• Cardiovascular Toxicity Induced by Antitumoral Drugs

Interventions

DEVICE

High efficiency particulate air filtration system (nightly administration)

Portable air purifier is programmed to provide a dose of filtered air at 275 m³/h nightly for at least 7 hours consecutive within a time window between 10:00 p.m. and 10:00 a.m. Air purifier is set up with active filters (HyperHEPA technology). Dose adjustments are permitted in the study where noise disturbance is an issue for participants. The air filtration therapy will be delivered in doses decreasing sequentially in terms of speed mode. Participants will be instructed to keep doors and windows of the bedroom closed during each session at night, and to follow a similar bedtime routine.

DEVICE

High efficiency particulate air filtration system (nightly and daily administration)

Portable air purifier set up with active filters (HyperHEPA technology) is continuously in operation (24 hours for 14 days) at 275 m³/h in bedrooms with the door and windows closed. During this open-labell phase, the participants will be asked to remain in the bedroom for as long as possible and to keep an activity log for the outdoor locations. Dose adjustments are permitted.

DEVICE

Air filtration system without filters (sham)

Portable air purifier is programmed to provide a dose of filtered air at 275 m³/h nightly for at least 7 hours consecutive within a time window between 10:00 p.m. and 10:00 a.m. Air purifier is set up with a sham filter, which is identical in appearance and noise as the HyperHEPA filter (active filter) when the air purifier is in operation. Dose adjustments are permitted in the study where noise disturbance is an issue for participants.

Sponsors & Collaborators

• IQAir AG

  collaborator UNKNOWN

• PremaLabs Diagnostics, Ltd

  collaborator UNKNOWN

• A&D Instruments, Ltd

  collaborator UNKNOWN

• Lansion Biotechnology Co. Ltd

  collaborator UNKNOWN

• University College, London

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-01-23

Primary Completion

2026-07-31

Completion

2026-07-31

Countries

• Spain

Study Locations