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

Inclusion Criteria34

• 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.
• 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).
• 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).
• 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).