Using air filtration at night to reduce inflammation in cancer survivors

A Series of N-of-1 Randomised, Adaptive, Blinded, Placebo-Controlled Trials of Overnight In-Bedroom Air Filtration as Adjuvant Treatment in Reducing Inflammatory Biomarkers Among Survivors of Adult-Onset Cancer With Elevated C-Reactive Protein

This study is testing if using air filters at night can help reduce inflammation and improve heart health in cancer survivors who are at risk for heart problems.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 10 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: University College, London (Academic / other)
• Drugs / interventions: nivolumab, ipilimumab, chemotherapy, immunotherapy, doxorubicin
• Locations: 3 sites (Valencia and 2 other locations)
• Trial ID: NCT06778122 on ClinicalTrials.gov

What this trial studies

The BREATHS trial investigates the effects of overnight air filtration on inflammation and cardiac biomarkers in adult cancer survivors at risk for cardiovascular issues. Participants will undergo individualized N-of-1 trials in their homes, alternating between filtered and unfiltered air over 14-day periods. The study aims to determine if air purification can serve as a non-pharmacological anti-inflammatory treatment, potentially improving health outcomes for this vulnerable population. Conducted in Valencia, Spain, the trial focuses on those with a history of specific cancers who have completed their treatment and are in remission.

Who should consider this trial

Good fit: Ideal candidates are adult cancer survivors aged 18 to 75 who have completed treatment and are in remission from specific types of cancer.

Not a fit: Patients with active metastatic disease or those who do not meet the inclusion criteria may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide cancer survivors with a non-drug method to reduce inflammation and improve cardiovascular health.

How similar studies have performed: While air filtration has shown promise in reducing inflammation in other high-risk groups, this specific application in cancer survivors is novel and has not been extensively tested.

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 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.
* Clinical evidence of cardiovascular, respiratory and/or musculoskeletal disease, and/or other controlled and stable chronic medical conditions will not be reason of exclusion.
* 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.
* Internet connection (Wi-Fi) in the house.
* Signed informed consent prior to commencement of specific protocol procedures.

Exclusion Criteria:

* 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.
* Current chronic anti-inflammatory drug prescriptions or other chronic drugs (e.g., antihypertensive drugs) will be no reason for exclusion if its use is continued for the duration of the trial period.
* 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.

Additional inclusion criteria (non-exclusive; when CRP test is unavailable in medical records) associated with high or very high cardiovascular (CV) toxicity risk factors (according to the European Society of Cardiology guidelines on Cardio-Oncology):

1. 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).
   * Current or concomitant cancer treatment.
   * Prior cardiotoxic cancer therapy (e.g., anthracycline, radiotherapy to left chest).
   * Lifestyle risk factors (history of smoking, body mass index \>30).
2. Specific cardiotoxic cancer therapies with a high risk of long-term CV complications (any of these):

   * Total lifetime cumulative dose anthracycline ≥ 250 mg/m2 doxorubicin equivalent.
   * High-dose anthracycline ≥ 250 mg/m2 doxorubicin equivalent.
   * High-dose RT \> 15 Gray (Gy) Mean Heart Dose (MHD).
   * Anthracycline ≥ 100 mg/m2 doxorubicin equivalent in combination with radiotherapy 5-15 Gy MHD.
   * Multitargeted tyrosine kinase inhibitors (TKI) targeting BCR-ABL and concomitant high-dose dexamethasone therapy \>160 mg/month.
   * Combination of RAF and MEK inhibition.
   * Single-agent immune checkpoints inhibitors (ICI) therapy followed by previous cardiotoxic cancer therapies: RT, anthracyclines, 5-fluorouracil, and TKI.
   * Combination of two types of ICI (anti-PD1, e.g., nivolumab and anti-CTLA-4, e.g., ipilimumab).
3. Moderate or severe cancer therapy-related CV toxicity detected during cancer treatment or new CV symptomatic/asymptomatic abnormalities at the end of cancer treatment (3 or 12 months after therapy).

Where this trial is running

Valencia and 2 other locations

• Gil y Morte Primary Care Practice — Valencia, Spain (Recruiting)
• Mallilla Primary Care Practice — Valencia, Spain (Recruiting)
• Russafa Primary Care Practice — Valencia, Spain (Recruiting)

Study contacts

• Study coordinator: Eva Hernandez-Garcia

Conditions Cancer Survivors; Cardiotoxicity; Cardiovascular Toxicity Induced by Antitumoral Drugs; Cancer survivors; Cardio-oncology rehabilitation; Inflammation; Air filtration systems; Air purifiers