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

Launched by UNIVERSITY COLLEGE, LONDON · Jan 10, 2025

Keywords

ClinConnect Summary

The BREATHS trial is studying whether using a special air filtration system in bedrooms can help reduce inflammation and improve heart health in adult cancer survivors who are at risk for heart problems caused by their cancer treatments. Participants will spend time in their homes, where they will experience both filtered and unfiltered air for 14 days at a time, over several weeks. The main goal is to see if this treatment lowers levels of a specific blood marker called C-reactive protein (CRP), which indicates inflammation in the body.

To be eligible for this study, participants need to be at least 18 years old, have completed their cancer treatment at least a year ago, and live in certain urban areas of Valencia, Spain, known for poor air quality. They should not be current smokers and must have certain levels of CRP that suggest they are at high risk for heart issues. Participants can expect to follow a structured schedule involving air filtration treatments and to have their health monitored throughout the study. This trial is not yet recruiting participants, but it's an important step in finding ways to support the health of cancer survivors dealing with heart-related complications.

Gender

ALL

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).