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

NCT06778122 | Recruiting

• 1 other identifier: 22105/001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 3

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.

Conditions

Cancer Survivors; Cardiotoxicity; Cardiovascular Toxicity Induced by Antitumoral Drugs

Keywords

Cancer survivors; Cardio-oncology rehabilitation; Inflammation; Air filtration systems; Air purifiers

Outcome Measures

Primary Outcomes (1)

• C-reactive protein (CRP)

  The primary outcome is the change in blood CRP concentrations. A portable point-of-care testing via capillary finger-prick microsampling will be used to measure the blood levels of CRP (5µl per participant once a week; measuring range, 0.48-200 mg/L).

  At baseline and in the day 7 and 14 of each period. In the same time interval in the morning (between 07:00-10:00 am).

Secondary Outcomes (3)

• Serum Amyloid A (SAA)

  At baseline and in the day 7 and 14 of each period. In the same time interval in the morning (between 07:00-10:00 am).

• Haemoglobin A1c (Hb1Ac)

  At baseline and in the day 7 and 14 of each period. In the same time interval in the morning (between 07:00-10:00 am).

• Systolic and diastolic blood pressure (BP)

  At baseline and in the day 7 and 14 of each period. In the same time interval in the morning (between 07:00-10:00 am) and before the blood collection and any medication and in a fasting condition.

Study Arms (4)

Air purifier nightly

ACTIVE COMPARATOR

Participants are exposed to filtered air (HyperHEPA filter) nightly in the bedroom, in 14-day periods, up to 3 treatment sets in 12 weeks (blinded phase). The blinded N-of-1 trial will last between 4 and 12 weeks per participant, depending on the treatment set(s) received (cycle 1, 2 and 3) to produce evidence of clinical benefit (CRP \< 2 mg/L or CRP reductions ≥ 35%).

Device: High efficiency particulate air filtration system (nightly administration)

Sham air filter

SHAM COMPARATOR

Participants receive an intervention of sham air purifiers nightly in the bedroom, in 14-day periods, up to 3 treatment sets in 12 weeks (blinded phase). The blinded N-of-1 trial will last between 4 and 12 weeks per participant, depending on the treatment set(s) received (cycle 1, 2 and 3) to produce evidence of clinical benefit (CRP \< 2 mg/L or CRP reductions ≥ 35%).

Device: Air filtration system without filters (sham)

Air purifier nightly and daily

EXPERIMENTAL

Participants are exposed to nightly and daily filtered air (HyperHEPA filter) in the bedrooms (open-label phase). The air purifier with active filter is continuously operated (24 hours for 14 days). Participants who do not achieve the clinically meaningful change established in the trial (CRP \< 2 mg/L or CRP reductions ≥ 35%) after the treatment set 3 (cycle 3) will take this open-label phase.

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

No treatment

NO INTERVENTION

14-day period of no intervention. Participants who do not achieve the clinically meaningful change established in the trial (CRP \< 2 mg/L or CRP reductions ≥ 35%) after the treatment set 3 (cycle 3) will take this open-label phase.

Interventions

High efficiency particulate air filtration system (nightly administration) DEVICE

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.

Air purifier nightly

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

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.

Air purifier nightly and daily

Air filtration system without filters (sham) DEVICE

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.

Sham air filter

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 prescribed for long-term, chronic use without interruption during the trial, or completed for at least ≥3 months before starting the trial.
• Having a high inflammatory cardiac risk profile at the initial screening defined as a CRP measurement ≥ 3 to \< 10 mg/L, or ≥ 10 mg/L if acute inflammation is ruled out.
• Having stable hypertension (if applicable): no medication changes in prior 30 days, systolic BP \<160 mm Hg and either ≥ 130 mm Hg without antihypertensive medications, or diagnosis of hypertension in medical records.
• Any medical prescription(s) if routinely administered and continued through the trial period.
• Living at one of the urban areas of the city of Valencia with the highest index impact of pollutant on population values (IIPP \> 125): Russafa, Malilla and Arrancapins neighbourhoods.
• Permanent residence in their usual home at least 3 months prior to the first collected blood sample in the first cycle and without plans to move out toward another dwelling during the trial study.
• Living in a non-smoking household.

You may not qualify if:

• Recently diagnosed with cancer or plans for additional cancer therapy and/or surgery during the trial period.
• Metastatic disease.
• Planned medication prescription to start during the trial.
• Having uncontrolled hypertension: participants with average systolic BP \>160 mmHg over any 10-day period prior and during the study.
• History of uncontrolled, unstable chronic disease as defined by clinical practice guidelines and documented in medical records - within past 6 months to screening visit(s) and during the study (i.e., uncontrolled diabetes mellitus). Psychiatric illness that would limit compliance with trial requirements and/or prevent the patient from giving informed consent.
• History of ongoing, chronic or recurrent infectious disease, and having suspected or proven immunocompromised state (i.e., Human Immunodeficiency Virus infection).
• Self-report of alcohol or substance abuse within the past 12 months, including at-risk drinking (current consumption of more than 14 alcoholic drinks per week).
• Shift workers or subjects who have the work schedule falling outside the hours of 07:00 a.m. and 10:00 p.m.
• Plans to move out of usual home during the trial period.
• Unwilling to spend at least 7-h/overnight in the bedroom.
• Pre-existing an air filtration system that improve household air quality. If so, the device will be disconnected during all the trial cycles.
• Unwilling to give consent.
• High or very high baseline CV toxicity risk pre-treatment (HFA-ICOS risk stratification score); risk factors including:
• Prior history of CV disease (e.g., coronary artery disease).
• Presence of multiple CV-risk factors (e.g., hypertension, dyslipidemia).

Sponsors & Collaborators

• University College, London: lead
• IQAir AG: collaborator
• PremaLabs Diagnostics, Ltd: collaborator
• A&D Instruments, Ltd: collaborator
• Lansion Biotechnology Co. Ltd: collaborator

Study Sites (3)

Gil y Morte Primary Care Practice

Valencia, Spain

RECRUITING

Mallilla Primary Care Practice

Valencia, Spain

RECRUITING

Russafa Primary Care Practice

Valencia, Spain

RECRUITING

MeSH Terms

Conditions

Cardiotoxicity; Inflammation

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Central Study Contacts

Eva Hernandez-Garcia

CONTACT

+44 (0)20 3108 3220; eva.hernandez.20@ucl.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: The sequence allocation will be masked for the participants, general practitioners, primary care staff and research team members, except for the field researcher to dispense the correct treatment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: N-of-1 trial design (multiple crossover trial design for single participants). N-of-1 series (aggregated N-of-1 trial). Each participant will be randomly allocated to 3 treatment sets or cycles, each comprising a 14-day period of active therapy and a 14-day period of sham intervention (placebo - standard of care).

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: January 23, 2026
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Access Criteria: Access to all information systems will be controlled to ensure that only authorised users have access to the system and the information they are authorised to access. Only the Field Researcher (Eva Hernandez-Garcia) and Principal Investigator (Emeritus Professor Andrew Edkins) will have complete access to the database.

Locations

ES (3)