Heart and Blood Diseases

All Conditions

Nutritional and Metabolic Diseases

Substance Related Disorders

Symptoms and General Pathology

Wounds and Injuries

Heart Failure

Vascular Diseases

Metabolic Diseases

Heart Diseases

Drug-Related Side Effects and Adverse Reactions

Cardiotoxicity

Chemically-Induced Disorders

Radiation Injuries

Drugs and treatments used in cancer inducing cardiovascular and metabolic side effects

Anti-Cancer Agents

Joe-Elie Salem, MD, PhD

Stéphane Edehry, MD

Edehry Stephane, MD

Joe-Elie Salem, Md, PhD

Several Drugs used in routine care in oncology induce rare but often severe or fatal cardiovascular or metabolic side effects. This study will investigate, evaluate, report and treat the cardiovascular side effects of anticancer drugs, through a specific cardiovascular routine checkup and follow-up taking place in several Cardio-oncology programs throughout France. The different including centers will be: Assistance Publique - Hôpitaux de Paris (APHP.6: Pitié-Salpétrière, Saint Antoine and Tenon's hospitals, Paris, France).

Several anticancer and supportive care drugs used in oncology have an impact on the cardiovascular and metabolic systems, leading to a wide range of cardiovascular and metabolic disorders and side effects. Those are poorly described, due to the evolution of the anticancer pharmacopeia, and recent recognition of these adverse events. This study will investigate the potential benefits of a specialized cardio-oncology check-up and follow-up in this context.

Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care

Groupe Hospitalier Pitie-Salpetriere

Assistant director, clinical investigation center Paris Est

Neoplasms

Blood and Lymph Conditions

Respiratory Tract (Lung and Bronchial) Diseases

Diseases and Abnormalities at or Before Birth

Rare Diseases

Hematologic Neoplasms

Respiratory Insufficiency

Syndrome

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Respiration Disorders

Respiratory Tract Diseases

Hematologic Diseases

Lung Diseases

Chronic Graft Versus Host Disease

Acute Graft Versus Host Disease

Respiratory Distress Syndrome, Infant

Acute Respiratory Distress Syndrome

NFHC-O2 therapy alone with gas flow at least 40L/min,

NIV sessions with at least 30% FiO2 and standard oxygen therapy

combination of NIV sessions and NFHC-O2 therapy,

NIV setting: minimal FiO2 0.3; tidal volume 6-8ml/kg (theoretical body weight)

NFHC-O2 setting: minimal FiO2 0.3; minimal flow 40l/min

NFHC-O2

Rene ROBERT, MD,PhD

Celine DELETAGE, CRA

René ROBERT, MD,PhD

Céline DELETAGE, CRA

ICU care of patients considered "palliative" but without contraindications to admission to intensive care, for whom a do-not intubate order decision was made upon admission represents a particular target for non-invasive oxygenation techniques. The benefits of non invasive ventilation (NIV) in this population are debated especially in cancer patients. The more recently used nasal humidified high flux canula oxygenation (HFNC) therapy may have benefits over NIV in these patients. It is supposed to have better tolerance and could allow better compliance and thus higher efficiency. These potential benefits are major for such a population for which tolerance and symptomatic relief are priority goals

Observational prospective multicenter study Primary outcome: To analyze the efficacy and tolerance of NIV and HFNC in patients admitted to intensive care unit, or intermediate catre unit for acute respiratory insufficiency for whom a a do-not intubate order decision was taken upon admission or after extubation if the patient initially received mechanical ventilation.

Secondary outcomes: To analyze the efficacy and tolerance of NIV and HFNC according to the following reason for ICU admission: chronic obstructive pneumopathy decompensated COPD, severe heart failure, evolutive cancer or hematologic malignancy; to analyze tolerance and acceptability of different techniques; to analyze the duration of the oxygenation methods use; to analyze the modalities of eventual withdrawing life support therapies and the associated sedative and opioid treatments; to analyze the satisfaction for the use of the non invasive technique by the relatives and the caregivers; to analyze mortality at D28 and D90 and quality of life at 3 and 6 months in surviving patients

Oxygenation Methods and Non-invasive Ventilation in Patients With Acute Respiratory Failure and a do Not Intubate Order

Evaluation of Oxygenation Methods and Non-invasive Ventilatory Support in Patients With Acute Respiratory Failure for Whom a Do-not Intubate Order Was Taken: Prospective Observational Study

Survival at day 14 in patients weaned from NIV and or HNFC-O2

respiratory rate improvement will be assessed by a decrease of respiratory rate below 20/min

sPO2 (oxygen saturation) expressed in % improvement will be assessed by an increase above 92%

tolerance will be assessed by comfort visual analogic scale from 1 worse tolerance to 10 very good tolerance; improvement defined as a 20% decrease of the value

quality of life will be measured by the EuroQuality of life 5D score (EQ5D) recording 5 subscore (mobility, autonomy, ability to perform current activities, pain, anxety/depression); the value of each is from 1 to 3 points; total score is the sum of the 5 subscores with a minimal score of 5 and a maximal score of 15. The baseline score will be recorded after admission in the ICU and reflects the patient's quality of life just before his or her admission. After 3 and 6 months, a higher value of the score will represent a worse outcome.

tolerance defined by the absence of refusal to continue the technique (NIV or HNFC O2) by the patient

percentage of patients deceased at day 28 whatever the cause of death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care	NCT03882580	Cardiovascular ... Cardiovascular ... Cardiac Complic... Oncologic Compl... Cardiac Insuffi... Metabolic Disor... Vascular Disord... Cardiac Disorde...	Anti-Cancer Age...	18 Years -	Groupe Hospitalier Pitie-Salpetriere
Oxygenation Methods and Non-invasive Ventilation in Patients With Acute Respiratory Failure and a do Not Intubate Order	NCT03673631	Acute Respirato... Cancer Hematologic Mal... Cardiac Insuffi... Chronic Respira...	NIV NFHC-O2	18 Years -	Poitiers University Hospital
Reporting, Evaluating, Preventing and Treating the Cardiotoxicity Induced by Anticancer Drugs During a Specific Cardio-oncology Consult and Follow up in Routine Care	NCT03882580	Cardiovascular ... Cardiovascular ... Cardiac Complic... Oncologic Compl... Cardiac Insuffi... Metabolic Disor... Vascular Disord... Cardiac Disorde...	Anti-Cancer Age...	18 Years -	Groupe Hospitalier Pitie-Salpetriere

Spots Global Cancer Trial Database for cardiac insufficiency